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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE; INSULIN INFUSION PUMP
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ANIMAS LLC 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
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 or Problem Description
On (b)(6) 2019, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.
 
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 16-apr-2019 with the following findings: during investigation, the pump powered on with a blank display.The complaint of a dim display was not able to be fully investigated due to the blank display issue.
 
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Brand Name
ANIMAS VIBE
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
MDR Report Key8455890
Report Number2531779-2019-02151
Device Sequence Number16848712
Product Code OYC
UDI-Device Identifier10840406103199
UDI-Public10840406103199
Combination Product (Y/N)Y
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P130007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 03/24/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Was the Report Sent to FDA? Yes
Device Age17 MO
Initial Date Received by Manufacturer 03/24/2019
Supplement Date Received by Manufacturer03/24/2019
Initial Report FDA Received Date03/27/2019
Supplement Report FDA Received Date04/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age18 YR
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