BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3863635 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16397
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY DOWNLOAD DOES NOT SHOW ANY "PRIME" OR ¿SUSPEND" ENTRIES. PRIME AND SUSPEND HISTORY WAS CHECKED IN THE PUMP; EACH CONTAIN ONLY ONE RECORD. PERFORMED MULTIPLE ¿PRIMES¿ AND ¿SUSPENDS¿ ON THE BENCH; THE PUMP¿S ELECTRONIC ERASABLE PROGRAMMABLE READ ONLY MEMORY MAINTAINS ONLY ONE VALUE OF "PRIME" AND "SUSPEND", THE LAST VALUE CREATED AND CORRUPTION OF THIS MEMORY WAS CONFIRMED ON THE BENCH. A BLUE LINE WAS OBSERVED UNDER THE ¿BASAL RATE¿ ON THE HOME SCREEN. REMOVED PUMP COVER; FAILED DISPLAY FLEX WAS CONFIRMED. NEW TEST SCREEN WAS INSERTED AND FOUND TO BE NEW TEST FULLY FUNCTIONAL WITH NO LINES.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A FAILED DISPLAY FLEX AND A CORRUPTED EPROM (ERASABLE PROGRAMMABLE READ ONLY MEMORY). THIS REPORT IS BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338515 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR