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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 Structural Problem (2506)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2018 with the following findings: during investigation, the battery compartment was found to be cracked.(b)(6).
 
Event or Problem Description
The pump was returned for investigation.Investigation revealed a cracked battery compartment and moisture within the pump.This report is made based on results of investigation completed on (b)(6) 2018.
 
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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 Key7845397
Report Number2531779-2018-15935
Device Sequence Number11146868
Product Code OYC
UDI-Device Identifier10840406100358
UDI-Public10840406100358
Combination Product (Y/N)Y
Initial Reporter StateAZ
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/09/2018
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 Manufacturer08/08/2018
Was the Report Sent to FDA? Yes
Device Age18 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/09/2018
Initial Report FDA Received Date09/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age15 YR
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