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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.
 
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
Follow-up #1 date of submission 06/02/2016 device evaluation: the pump has been returned and evaluated by product analysis on 05/17/2016 with the following findings: a review of the black box data showed an unexplained reboot on (b)(6) 2016. A visual inspection of the pump showed that the battery compartment was cracked. Evidence of moisture contamination was observed in the battery compartment. The returned battery cap was unable to fully tighten on to the pump; however, the pump powered on with the cap. The pump was then exercised for 24 hours with no power issues. The pump failed a leak test at the battery compartment. The pump cover was opened and no additional moisture was observed. The complaint was not duplicated during testing.
 
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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 Key5588227
MDR Text Key43797902
Report Number2531779-2016-08137
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 04/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610004421075606216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age13 MO
Event Location No Information
Date Manufacturer Received04/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2015
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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