BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4213451 · Received October 30, 2014

    Report

    Report Number
    2531779-2014-30872
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/08/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A TEST BATTERY CAP WAS USED TO COMPLETE TESTING. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AT THE OPENING. 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.

    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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE USER HAD DIFFICULTY REMOVING THE BATTERY CAP FROM THE PUMP FOR A BATTERY CHANGE. THE REPORTER NOTED THAT THE BATTERY CAP EVENTUALLY WAS REMOVED WITH USE OF PIERS. THE REPORTER STATED THAT THE USE THEN INSERTED A NEW BATTERY AND PUT A NEW BATTERY CAP ON THE PUMP, BUT THE NEW CAP DID NOT ATTACH PROPERLY, AS IF THERE WAS AN ISSUE WITH THE BATTERY COMPARTMENT THREADS. 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
    695447 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1