Replies to This Discussion

Permalink Reply by marti w on January 11, 2011 at 5:07pm

haven't heard anything specific but here's the page to watch for new things at

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Devi...

Permalink Reply by Zoe on January 11, 2011 at 5:11pm

Hi Dave

I talked to my sales rep at Animas about that when I ordered my Ping just a couple weeks ago, because I was thinking of waiting if the integrated system was iminent. He said that the process with the FDA was always a moving target, but that they were looking at probably the very end of 2011 or January, 2012. Some other people I spoke to were cynical, saying they've been talking about it being "out in a year" for some time now. But my own decision to go ahead and get my ping was made when he said that when it came out I could upgrade for $300, so there was no reason to hold off. I don't know anything about the sensors. I'm sure Animas could tell you that though.

Permalink Reply by Phil Lindner on January 11, 2011 at 5:40pm

The last thing I saw was DexCom, who's making the CGMS portion of the product, did not receive FDA approval for their next generation sensors. From what I saw it's nothing major but the FDA wanted significant more information than provided before they would approve the sensors. That would delay any products depending on the new sensor for at least six months.

Permalink Reply by Amy on January 11, 2011 at 7:36pm

from what I have heard that the FDA needs more information before they approve for the device. I know that the next generation of the dexcom got sent back for more info as well. The FDA is getting stricter on what they are allowing on the market and what they need more info on

Permalink Reply by Maru on June 10, 2012 at 9:32am

Any news about the animas new pump??
I am about to change mine and i need to know ... Also does anyone know if I get the animas ping and then 1-2 months after the newest pump come to the market, does Animas honor and change it for you ?

I appreciate your responses please

Thanks
Mariana

Permalink Reply by Zoe on June 10, 2012 at 10:34am

See my comment above, Maru about the upgrade. Also, you might want to talk to your animas sales rep.

Permalink Reply by hulachickie on June 10, 2012 at 9:15pm

it was my understanding that they would be clearing the same system that is currently widely available in europe. If you go to the animas page for the UK you can read about it.

Permalink Reply by Prisoner on July 7, 2012 at 7:34pm

In New Zealand we have been told the end of August 2012.. I would love to read some reviews before it arrives :)

Permalink Reply by John Emrys on August 9, 2012 at 7:23pm

FDA Report Site: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cf...

Looks Like User Error...This is what happens when you do not check your battery - Plus alarm setting was on LOW - Check your alarm settings

MAUDE Adverse Event Report: ANIMAS CORPORATIONANIMAS VIBEINSULIN INFUSION PUMP

ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP
Results
Model Number ANIMAS VIBE INSULIN PUMP
Event Date 04/27/2012
Event Type Injury Patient Outcome Life Threatening
Event Description

On (b)(6) 2012 the patient reported that the pump powered off while she slept overnight. The patient denied previous power issues. She said that the battery was original to the pump which she began to use one week ago. The patient reported that her blood glucose (bg) was 19mmol/l and stated that she felt nauseous and unwell. She stated that she powered up the pump with a new battery and delivered correction bolus via the pump. The patient inspected the pump and denied damage to the pump or battery cap. She claimed that the battery symbol showed a full charge on (b)(6) 2012. Review of the alarm history showed a replace battery alarm at 7:55am. The patient claimed that she did not hear the replace battery alarm. There was no allegation that the audible alarm system was not functional. Customer technical support assisted with changing the alarm setting to high as it was previously set to low. This complaint is being reported because the patient experienced a serious bg excursion due power loss after inadequate response to a replace battery alarm.

Manufacturer Narrative

The pump has not been requested for return to animas for evaluation at this time. Customer support concluded that use error caused the event and that there was no malfunction detected. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release. If the device is returned, an evaluation shall be completed and a supplemental report will be filed.

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

Brand Name ANIMAS VIBE
Type of Device INSULIN INFUSION PUMP
Manufacturer (Section F)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
kelly stone
200 lawrence dr
west chester , PA 19380-3428
(408) 956 -4746
Device Event Key 2616267
MDR Report Key 2587567
Event Key 2484260
Report Number 2531779-2012-04503
Device Sequence Number 1
Product Code LZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/27/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 05/24/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number ANIMAS VIBE INSULIN PUMP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Device Age
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 04/27/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured 10/17/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Permalink Reply by Jay on August 11, 2012 at 11:17am

QUESTION: How was this reported to FDA if it is not approved for USA usage?

Permalink Reply by John Emrys on August 11, 2012 at 5:58pm

Supposedly there were trials in the USA - Also Since there are people from EU in the USA with the vibe. Go to the link which is FDA and this was as you can see this was a user error.

Permalink Reply by Jay on August 11, 2012 at 10:23pm

Any way you slice it and dice it, it is very interesting. I went to the completed clin trials at FDA and cannot find they have occured in the USA. What I am believing is Animas is going to submit European data once Dexcom gets the FDA blessing for G4 sensors. .... Go figure....

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