BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811124 · Received August 13, 2010

    Report

    Report Number
    2183996-2010-01607
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT RECEIVED THE BATTERY DEPLETED (E2) ERROR WITHOUT RECEIVING THE BATTERY LOW (A2) ALERT FIRST. THIS WAS CONFIRMED BY VIEWING THE ALARM HISTORY ON THE INFUSION DEVICE. PT WAS USING THE CORRECT TYPE OF BATTERY. FOLLOWING BATTERY DEPLETED (E2) ERROR, PT TRIED SEVERAL BATTERIES THAT DID NOT WORK. PT THEN INSERTED A USED BATTERY AND INFUSION DEVICE POWERED ON. AFTER INFUSION DEVICE POWERED ON, IT THEN DISPLAYED BATTERY LOW (A2) ALERT. BATTERY WAS REPLACED AGAIN AND INFUSION DEVICE POWERED ON WITHOUT GIVING ANY BATTERY ALERTS OR ERRORS. PT ALSO RECEIVED A MECHANICAL ERROR (E6) EARLIER IN THE DAY, WHICH WAS CLEARED BY FOLLOWING TROUBLESHOOTING STEPS. INFUSION DEVICE WAS REPLACED AND 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.

    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 48 YR INSULIN| INFUSION SET