BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3935299 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20102
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 23, 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW IF THE BLACK BOX INDICATED LOSS OF PRIME WARNING(S) HAD OCCURRED. THERE WAS NO EVIDENCE OF UNSUCCESSFUL ATTEMPTS TO PRIME OR ANY OTHER PRIME ISSUES NOTED. THE PUMP POWERED ON NORMALLY WITHOUT ISSUES, AND THE PUMP¿S AUDITORY AND VIBRATORY FEATURES FUNCTIONED NORMALLY. THE PUMP PERFORMED A REWIND, LOAD, AND PRIME SEQUENCE WITHOUT ANY ALARMS OR WARNINGS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP KEPT ALARMING THAT THE CARTRIDGE WASN¿T FILLED. REPORTEDLY, THE PATIENT FILLED THE CARTRIDGE AND THEN FILLED THE CANNULA, BUT THEN PUMP KEPT ALARMING. THE PATIENT REPORTEDLY CHANGED OUT ALL THE SUPPLIES AND TRIED AGAIN, WITH THE ALARM PERSISTING. 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
    413689 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1