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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 Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has not been returned to animas. 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. (b)(6).
 
Event Description
On (b)(6) 2016 the reporter contacted animas alleging that on (b)(6) 2016 the battery became very warm so that the patient could not hold the pump. There is no indication that the product issue caused or contributed to an adverse event. This complaint is being reported because the issue remained unresolved.
 
Manufacturer Narrative
Follow-up #1: date of submission 04/26/2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2016 with the following findings: a review of the black box indicated a drastic voltage drop that led to the pump getting warm on (b)(6) 2016. No activity outside normal use was found in the pump histories for (b)(6) 2016. Visual inspection did not find any damage to the battery compartment or cap. The pump powered on normally and successfully completed rewind, load, and prime steps. All current draws were within specifications during investigation; no overheating occurred. The pump cover was removed and no internal defects were found. The complaint could not be duplicated on investigation. Unrelated to the complaint, investigation revealed that the display was dim and discolored. 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 Key5543687
MDR Text Key41958039
Report Number2531779-2016-07055
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 distributor,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2016
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 Manufacturer04/04/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age45 MO
Event Location No Information
Date Manufacturer Received03/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
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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