BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3873393 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-17040
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 27, 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

    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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/10/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED THE LAST DATA WAS RECORDED ON (B)(6) 2014. DATA FROM (B)(6) 2014 HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. REVIEW OF THE ALARM HISTORY REVEALED TWO CALL SERVICE ALARMS (012-0195) RECORDED ON (B)(6) 2014. ON INVESTIGATION, THE PUMP WAS EXERCISED FOR 24 HOURS BOLUSES WERE DELIVERED CORRECTION WITHOUT ALARMS OR WARNINGS. INVESTIGATION DID NOT DUPLICATE THE ALLEGED CALL SERVICE ALARM AND THE PUMP WAS DETERMINED TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. UNRELATED TO THE ORIGINAL COMPLIANT, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED FROM THE FINGER GRIP DOWN TO THE CASE SEAL, AND THE DISPLAY WAS FOUND TO BE DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 012) 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
    349891 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1