BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4112817 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27209
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 10, 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/18/2014 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED THAT THE PUMP COULD NOT BE PRIMED DUE TO REPLACE BATTERY ALARMS FOLLOWING THE REWIND STEP. DURING TESTING, THE REWIND, LOAD, AND PRIME STEPS WERE COMPLETED SUCCESSFULLY WITH NO ISSUES PREVENTING THE STEPS FROM BEING COMPLETED. THE PUMP WAS EXERCISED FOR 24 HOURS, AND THE PUMP EMITTED A LOW BATTERY WARNING. THE SLEEP CURRENT DRAW DID NOT MEASURE WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF MOISTURE INGRESS WAS FOUND. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS USED TO COMPLETE INVESTIGATION. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON WAS UNRESPONSIVE TO USER PRESSES DUE TO MOISTURE DAMAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (UNABLE TO PRIME) 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
    596156 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1