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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 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. 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.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a power (intermittent power) issue. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 06/07/2016 with the following findings: several por events observed in black box. Cracks in battery compartment above grip pad to threads, and below grip pad to case seal. The battery cap is able to fit to maintain electrical connection. The pump powers on correctly no power interruption was duplicated during investigation. Tightened battery cap fully then loosened one half turn, power to pump was not interrupted. Opened pump, no intermittent conditions found on power pcb. 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 Key5667113
MDR Text Key45528692
Report Number2531779-2016-10259
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2016
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 Manufacturer05/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age28 MO
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2014
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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