BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4871389 · Received June 26, 2015

    Report

    Report Number
    2531779-2015-21258
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Report Date
    June 10, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/23/2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/08/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A VISUAL INSPECTION OF THE PUMP REVEALED A CRACK IN THE BATTERY COMPARTMENT BELOW THE BUMPER PAD AND ON THE SIDE, EXTENDING FROM THE THREADS TOWARDS THE CASE SEAL. MOISTURE CORROSION WAS OBSERVED INSIDE THE BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS TORN/PUNCTURED. THE AUDIO BOLUS BUTTON WAS DIFFICULT TO PRESS, BUT RESPONDED APPROPRIATELY TO BUTTON PRESSES. THE BUTTON COVER WAS REMOVED AND THE BUTTON SLUG WAS FOUND TO BE MISALIGNED. THERE WAS MOISTURE FOUND IN THE BOLUS BUTTON ASSEMBLY.

    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

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT HAD A SMALL CRACK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414942 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1