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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 Slipped (1584)
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 06/23/2016 with the following findings: investigation revealed a cracked battery compartment. In addition, the battery cap threads were stripped and would not secure to the pump. (b)(6).
 
Event Description
The pump was returned for investigation. This report is made based on results of investigation completed on 06/23/2016. Investigation revealed a cracked battery compartment. In addition, the battery cap threads were stripped and would not secure to the pump.
 
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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 Key5799531
MDR Text Key50403752
Report Number2531779-2016-16364
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 06/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
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 Manufacturer06/17/2016
Was the Report Sent to FDA? Yes
Device Age21 MO
Event Location No Information
Date Manufacturer Received06/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2014
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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