BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4101901 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26829
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/02/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/12/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE THREADS, DOWN TO THE CASE SEAL ON THE SIDE. THERE WAS ALSO MOISTURE AND CORROSION OBSERVED IN THE BATTERY COMPARTMENT AND ON THE BATTERY CAP. THE BATTERY COMPARTMENT WAS ALSO FOUND TO BE LEAKING DURING A LEAK TEST. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN HAD A MISSING PIXEL LINE UPON STARTUP OF THE PUMP. A TEST DISPLAY WAS INSERTED AND THE DISPLAY WAS SCREEN WAS CLEAR AND FUNCTIONING. THE PUMP¿S COVER WAS REMOVED; THERE WAS NO FURTHER MOISTURE/CORROSION FOUND INSIDE THE PUMP OR THE PCB. 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 CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE. THERE WAS REPORTEDLY MOISTURE IN THE BATTERY COMPARTMENT AND IT WAS CRACKED. 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
    582656 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1