BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3932011 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19874
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF MOISTURE INGRESS, NO EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS OR ON THE SCREEN, AND NO EVIDENCE OF MOISTURE IN THE BATTERY OR CARTRIDGE COMPARTMENTS. A CRACK IN THE BATTERY COMPARTMENT WAS OBSERVED BELOW THE FINGER PAD EXTENDING TO THE PRIMARY SEAL; A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS OBSERVED. THE PUMP WAS OPENED TO CHECK FOR INTERNAL MOISTURE DAMAGE AND THERE WAS NO EVIDENCE OF MOISTURE DAMAGE FOUND ON THE INTERNAL COMPONENTS OR PRINTED CIRCUIT BOARD. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE. THE REPORTER STATED THAT THERE WAS A CRACK IN THE BATTERY COMPARTMENT AND MOISTURE OR CORROSION IN THE PUMP. REPORTEDLY, THERE WAS NO DAMAGE TO THE BATTERY CAP. 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
    409684 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR