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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP

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ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problems No Display/Image (1183); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has not been returned to animas for evaluation. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Event Description
On 04/30/2016, the reporter contacted animas, alleging that the display screen would go blank, then come back on for a period of time, and then go blank again. There was no indication that the device caused or contributed to an adverse event. This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.
 
Manufacturer Narrative
Follow-up #1 date of submission 06/28/2016. Device evaluation: the pump has been returned and evaluated by product analysis on 06/06/2016 with the following findings: a visual inspection of the pump showed that there was visible moisture behind the display lens and the battery compartment was observed to be cracked. During testing, the pump powered on and then restarted. The pump failed a leak test at the battery compartment crack. The pump cover was opened and moisture corrosion was found. 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.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
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
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key5682259
MDR Text Key46010693
Report Number2531779-2016-10565
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 04/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2016
Was the Report Sent to FDA? Yes
Device Age16 MO
Event Location No Information
Date Manufacturer Received04/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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