BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1851253 · Received September 23, 2010

    Report

    Report Number
    2183996-2010-01955
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, CARETAKER REPORTED ALL BUTTONS ON THE INFUSION DEVICE WERE UNRESPONSIVE. THIS WAS NOTICED ON DAY OF REPORT WHEN PT ATTEMPTED TO DELIVER A MEAL BOLUS. INFUSION DEVICE HAD POWER AND WAS STILL DELIVERING BASAL INSULIN, BUT PT WAS UNABLE TO PROGRAM A BOLUS INFUSION DEVICE BATTERY WAS REPLACED, USING A NEW BATTERY OF CORRECT TYPE, AND ALL BUTTONS REMAINED UNRESPONSIVE. INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE. BUTTONS DO NOT PRODUCE AN AUDIBLE SOUND WHEN PRESSED, AND BUTTONS POP UP BEING PRESSED. PT SWITCHED TO BACKUP INFUSION DEVICE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR INSULIN| INSULIN INFUSION SET