BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3944202 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20632
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF SHORT BATTERY LIFE OBSERVED IN THE BLACK BOX HISTORY. THERE WAS A REPLACE BATTERY ALARM ON (B)(6) 2014 AS A RESULT OF A DISCHARGED REPLACE BATTERY USE. CURRENT ELECTRICAL DRAWS WERE WITHIN SPECIFICATION AND NO ERRORS, ALARMS, OR WARNINGS OCCURRED DURING THE INVESTIGATION. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. THERE WAS NO INTERNAL DAMAGE FOUND WHEN THE PUMP¿S COVER WAS REMOVED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED. ALSO UNRELATED, THE RETURNED BATTERY CAP¿S THREADS WERE STRIPPED AND THE CAP WAS UNABLE TO SECURE TO THE PUMP, SO A TEST CAP WAS USED. 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. (B)(6).

    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
    422907 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1