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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 Crack (1135); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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. 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 an intermittent power issue with the device. The battery compartment reportedly was cracked. There was no indication of damage to the battery cap and no visible yellow o-ring; however, the battery cap was never replaced. 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: 06/01/2016. Device evaluation: the device has been returned and evaluated by product analysis on 05/11/2016 with the following findings: there was one unexplained power on reset event observed in the black box on (b)(6) 2016. The battery compartment was observed to be cracked along the side. There was no evidence of physical damage to the battery cap or battery compartment threads. The pump was exercised for 24 hours with no further loss of power occurring. The reported intermittent power issue was not duplicated during the investigation. 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 Key5594369
MDR Text Key43891547
Report Number2531779-2016-08194
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 04/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2016
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 Manufacturer04/26/2016
Was the Report Sent to FDA? Yes
Device Age18 MO
Event Location No Information
Date Manufacturer Received04/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2014
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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