BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6197410 · Received December 21, 2016

    Report

    Report Number
    2531779-2016-34502
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/22/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/03/2017 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE BLACK BOX DID NOT SHOW ANY EVIDENCE OF SHORT BATTERY LIFE. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION; A TEST CAP WAS USED TO COMPLETE TESTING. THE PUMP POWERED ON WITH THE TEST PUMP AND DID NOT DRAW EXCESSIVE CURRENT. A BATTERY LIFE ISSUE COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM. 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
    847237 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1