BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3970150 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21905
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 22, 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 10/22/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND HISTORY RECORDED MULTIPLE CALL SERVICE ALARMS THAT HAD ALSO OCCURED DURING THE INVESTIGATION AND WHICH PROHIBITED PUMP PRIME AND FAILED STEPS TESTING. THE PUMP WAS OPENED, THE MOTOR WAS REMOVED AND TESTED ON A 5V POWER SUPPLY WHICH INDICATED NO SIGNS OF MOVEMENT. THE CARTRIDGE CAP WAS NOT RETURNED; A TEST CAP WAS USED TO COMPLETE THE INVESTIGATION. THE RETURNED BATTERY CAP WAS USED TO COMPLETE THE INVESTIGATION WITH NO ISSUES REPORTED. 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 PRIME (UNABLE TO PRIME) ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE. 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
    448352 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1