BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2150257 · Received June 10, 2011

    Report

    Report Number
    2183996-2011-01661
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 19, 2011
    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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE AUDIO-SIGNAL OF THE INFUSION DEVICE IS DEFECTIVE. THIS HAS OCCURRED INTERMITTENTLY OVER THE PAST MONTH WHEN THE INFUSION DEVICE GIVES CONFIRMATION BEEPS DURING BOLUS DELIVERY. THE CORRECT BOLUS AMOUNTS ARE LISTED IN THE INFUSION DEVICE HISTORY, AND THE BUTTONS FUNCTION AS INTENDED. INFUSION DEVICE WAS NOT DROPPED. 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 55 YR INSULIN INFUSION SET| INSULIN