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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 Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 12/09/2016 with the following findings: investigation revealed that the display was dim with discolored text. Unrelated to this issue, investigation revealed the audio bolus button cover was missing from the pump.
 
Event Description
The pump was returned for investigation. Investigation revealed that the display was dim with discolored text. There was no adverse event associated with this complaint. This report is made based on results of investigation completed on 12/09/2016.
 
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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 Key6219920
MDR Text Key63955152
Report Number2531779-2017-00091
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 12/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2016
Was the Report Sent to FDA? Yes
Device Age43 MO
Event Location No Information
Date Manufacturer Received12/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2013
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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