BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2932131 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00062
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DAUGHTER REPORTED THE INFUSION DEVICE FAILED TO PROVIDE AN A1 CARTRIDGE LOW AND E1 CARTRIDGE EMPTY ERROR. THE CARTRIDGE WAS EMPTY WHEN IT WAS REMOVED FROM THE INFUSION DEVICE. SHE HAD ALREADY RESET THE PISTON ROD AND WAS UNABLE TO CHECK THE VOLUME INDICATOR ON THE INFUSION DEVICE. THERE WAS NO LEAKAGE IN THE SYSTEM, AND THE CARTRIDGE WAS FULL (315 UNITS) AT THE TIME OF INSERTION. THE INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28394 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP