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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
Submitted: 14-aug-2018.The pump has been returned and evaluated by product analysis on 09-aug-2018 with the following findings: device evaluation: on investigation, the battery compartment was noted to be cracked.
 
Event or Problem Description
The pump was returned for investigation.Investigation revealed a case/condition issue.This report is made based on results of investigation completed on 09-aug-2018.
 
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Brand Name
ANIMAS VIBE
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
200 lawrence dr
west chester PA 19380 3428
MDR Report Key7782035
Report Number2531779-2018-14781
Device Sequence Number13706319
Product Code OYC
UDI-Device Identifier10840406100198
UDI-Public10840406100198
Combination Product (Y/N)Y
Initial Reporter StateMD
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) 07/26/2018
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 Manufacturer08/06/2018
Was the Report Sent to FDA? Yes
Device Age22 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/26/2018
Initial Report FDA Received Date08/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age54 YR
Patient Weight175
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