BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3871869 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16936
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE DAMAGE WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THERE WAS CORROSION INSIDE THE BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE DISTRIBUTOR ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED/DAMAGED. 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
    349678 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1