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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); Material Discolored (1170); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 07/07/2016 with the following findings: investigation revealed an intermittently responsive audio bolus button. Upon removal of the bolus button cover, contaminants were found on the contact. In addition, the battery compartment was cracked and 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. (b)(6).
 
Event Description
The pump was returned for investigation. This report is made based on results of investigation completed on 07/07/2016. Investigation revealed an intermittently responsive audio bolus button. In addition, the battery compartment was cracked and the display was dim and discolored.
 
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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 Key5830545
MDR Text Key51933652
Report Number2531779-2016-17870
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 company representative
Type of Report Initial
Report Date 07/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2016
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 Manufacturer07/01/2016
Was the Report Sent to FDA? Yes
Device Age38 MO
Event Location No Information
Date Manufacturer Received07/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2013
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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