BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2141019 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01616
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    February 22, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE INFUSION DEVICE DISPLAYED A2 LOW BATTERY ALERT ON (B)(6) 2011. THE INFUSION DEVICE WAS IN THE RUN MODE, AND PT CHANGED THE BATTERY. THE INFUSION DEVICE WOULD NOT START UP AFTER A NEW BATTERY WAS INSERTED, AND PT TRIED SEVERAL NEW BATTERIES. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS EVALUATED, AND THE COMPLAINT WAS VERIFIED. THERE IS A SHORT CIRCUIT ON THE FORCE SENSOR. DUE TO THIS DEFECT, THE INFUSION DEVICE SHUT DOWN OUT OF THE RUN MODE. FROM THE MOMENT, THE INFUSION DEVICE NO LONGER DELIVERED ANY INSULIN. E7202 ERROR WAS FOUND IN THE INFUSION DEVICE HISTORY, AND THIS WAS CORRECTLY TRIGGERED DUE TO THE SHORT CIRCUIT ON THE FORCE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET