BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4071285 · Received September 9, 2014

    Report

    Report Number
    2531779-2014-25532
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Report Date
    August 20, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 12/03/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/14/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE BLACK BOX SHOWED NO CALL SERVICE 064 ALARMS. MULTIPLE CALL SERVICE 054/052 ALARMS WERE OBSERVED IN THE BLACK BOX ON 07/15/2014. THE PUMP POWERED ON NORMALLY TO THE VERIFY SCREEN. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE AND WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OCCURRING. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED AND THE BATTERY COMPARTMENT WAS CRACKED IN MULTIPLE AREAS. 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 HAD EMITTED CALL SERVICE 064 ALARMS THAT COULD NOT BE CLEARED. 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
    553577 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1