BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4092918 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26374
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 29, 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 11/10/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO DAMAGE FOUND TO THE RETURNED BATTERY CAP; THE BATTERY CAP SECURED TIGHTLY TO THE PUMP AND MAINTAINED AN ELECTRICAL CONNECTION. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED FROM THE GRIP DOWN TO THE CASE SEAL. THERE WAS ALSO MOISTURE AND CORROSION OBSERVED TO THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT WAS FOUND TO BE LEAKING DURING A LEAK TEST. THE PUMP¿S COVER WAS REMOVED; THERE WAS NO MOISTURE INGRESS FOUND INSIDE THE PRINTED CIRCUIT BOARD (PCB). ALSO UNRELATED TO THE COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE PINKISH. 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 (MOISTURE INGRESS) ISSUE. THERE WAS REPORTEDLY MOISTURE BEHIND THE DISPLAY. THERE WAS NO ALLEGATION THAT THE DISPLAY SCREEN WAS NOT LEGIBLE AND THERE WAS NO INDICATION THAT THERE WAS ANY DAMAGE TO THE PUMP. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573592 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1