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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 Break (1069); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a power (damage) issue. Reportedly, the pump had an intermittent power issue and the battery compartment was damaged. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
 
Manufacturer Narrative
Follow-up #1: date of submission 09/21/2016. Device evaluation: the device has been returned and evaluated by product analysis on 08/26/2016 with the following findings: a review of the black box showed multiple unexpected reboots had occurred. The battery compartment was cracked and there was moisture corrosion observed in the battery compartment. Leak testing revealed a battery compartment leak. The returned battery cap was able to secure and maintain electrical connection. The battery cap was fastened and then unscrewed a half turn, and the pump rebooted. The battery cap was fastened and the pump was exercised for 24 hours with no further power interruptions occurring. The pump cover was removed and further moisture was found inside the battery canister.
 
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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 Key5834172
MDR Text Key52110105
Report Number2531779-2016-18128
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 07/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610005121706796416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age15 MO
Event Location No Information
Date Manufacturer Received07/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2015
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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