BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3863699 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16363
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE THREADS WITH VISIBLE MOISTURE CORROSION INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP FOR INVESTIGATION WAS INTACT, WITHOUT DAMAGE AND ABLE TO BE FASTENED PROPERLY TO THE PUMP. LEAK TESTING REVEALED A LEAK AT THE BATTERY COMPARTMENT. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF MOISTURE ON THE INTERIOR PUMP COMPONENTS OR THE PRINTED CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

    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. (B)(6).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE PUMP HAD A CRACKED BATTERY COMPARTMENT WITH MOISTURE CORROSION PRESENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338244 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR