BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4113717 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27292
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/22/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA DID NOT REVEAL ANY RECORDS SUGGESTIVE OF SHORT BATTERY LIFE. CONSECUTIVE POWER ON RESET RECORDS WERE OBSERVED ON (B)(6) 2014. THE BATTERY VOLTAGE PRIOR TO THE POWER ON RESET EVENTS WAS ABOVE THE BATTERY ALARM/WARNING THRESHOLD. THE BATTERY CAP AND COMPARTMENT WERE INTACT WITHOUT DAMAGE. THE BATTERY CAP SECURED TO THE PUMP PROPERLY. THE SLEEP CURRENTS WERE NOTED TO BE ABOVE SPECIFICATIONS. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE CORROSION ON THE POWER CIRCUIT, PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. 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
    594936 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1