BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2112218 · Received April 29, 2011

    Report

    Report Number
    2183996-2011-01287
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 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
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE INFUSION DEVICE FAILED TO ALARM E1 CARTRIDGE EMPTY. THE INSULIN CARTRIDGE WAS EMPTY AND THE INFUSION DEVICE WENT INTO THE STOP MODE. THE A1 LOW CARTRIDGE ALERT DID APPEAR WHEN THERE WERE 20 UNITS OF INSULIN REMAINING. PATIENT WOKE UP AND HIS BLOOD GLUCOSE WAS 400 MG/DL. NORMAL BLOOD GLUCOSE IS 100 MG/DL, AND HE CHANGED THE CARTRIDGE AND DELIVERED CORRECTION BOLUSES UNTIL HIS BLOOD GLUCOSE RETURNED TO NORMAL. ALARM HISTORY WAS VERIFIED, AND THE E1 CARTRIDGE EMPTY ERROR DID NOT OCCUR. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER. INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION. THE PATIENT 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 79 YR INSULIN INFUSION SET| INSULIN