BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2800134 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01597
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT'S MOTHER REPORTED THE INFUSION DEVICE HAS BLACK SPLOTCHES ACROSS THE DISPLAY AND THEY ARE UNABLE TO READ THE INDICATING INSULIN AMOUNTS. HAD MOTHER ATTEMPT TO INSERT A NEW BATTERY; ISSUE PERSISTS. HAD PT SWITCH TO HIS BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, BATTERY AND BATTERY COVER FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES