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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
Medical Device Problem Code Image Display Error/Artifact (1304)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 07/20/2017 with the following findings: during investigation, the pump was powered on and the display remained blank.A failed display flex was found.
 
Event or Problem Description
The pump was returned for investigation.Evaluation revealed that the display remained blank.A failed display flex was found.There was no adverse event associated with this complaint.This report is made based on results of investigation completed on 07/20/2017.
 
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Brand Name
ANIMAS VIBE
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
MDR Report Key6798859
Report Number2531779-2017-18388
Device Sequence Number1570599
Product Code OYC
UDI-Device Identifier10840406100358
UDI-Public0110840406100358
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P130007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2016
Was the Report Sent to FDA? Yes
Device Age18 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/20/2017
Initial Report FDA Received Date08/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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