BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3842245 · Received May 31, 2014

    Report

    Report Number
    2531779-2014-15394
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 12, 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 08/08/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE DEVICE'S BLACK BOX HISTORY SHOWED NO EVIDENCE OF A POWER ISSUE ON THE EVENT DATE. NO DAMAGE WAS FOUND TO THE RETURNED BATTERY CAP OR THE BATTERY COMPARTMENT. THERE WAS NO VISIBLE MOISTURE OBSERVED IN THE DISPLAY LENS. DAMAGE TO THE PUMP CASE WAS OBSERVED BETWEEN UPPER RIGHT CORNER OF THE DISPLAY LENS AND THE CASE SEAL. THE RETURNED BATTERY CAP FULLY ATTACHED TO THE PUMP WITH NO YELLOW O RING SHOWING. THE PUMP COMPLETED A 24 HOUR DURATION TEST WITH RETURNED BATTERY CAP. NO POWER INTERRUPTIONS WERE DUPLICATED DURING THE DURATION TEST. THE PUMP FAILED A LEAK TEST DUE TO THE DAMAGE TO THE PUMP CASE. THE PUMP COVER WAS REMOVED AND INTERNAL MOISTURE WAS PRESENT IN PUMP. UNRELATED TO THE POWER ISSUE, THE DISPLAY SCREEN WAS OBSERVED TO HAVE PINKISH CONTRAST. 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 THERE WAS MOISTURE IN THE PUMP AND THAT IT HAD CEASED TO FUNCTION. 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
    320399 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1