BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2110216 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01436
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 25, 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 Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED HIS INFUSION DEVICE STARTED MESSING UP ON HIM. PATIENT STATED HIS BLOOD GLUCOSE LEVEL WAS ELEVATED UP AROUND 13.9 MMOL/L (250 MG/DL). PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 6-8 MMOL/L (108-144 MG/DL). PATIENT REPORTED HE LOOKED AND HIS INSULIN CARTRIDGE HAD AIR IN IT. PATIENT STATED HE TOOK THE CARTRIDGE OUT TO TAP THE BUBBLES UP TO THE TOP AND WHEN HE PUT THE CARTRIDGE BACK IN AND ATTEMPTED TO PRIME, HE RECEIVED AN E10 (CARTRIDGE ERROR) MESSAGE. PATIENT REPORTED HE TURNED THE INFUSION DEVICE BACK TO STOP AND WHEN HE RESTARTED IT THE INFUSION DEVICE GAVE AN A2 (BATTERY LOW) ERROR MESSAGE. PATIENT STATED HE CHANGED THE BATTERY AND THEN RECEIVED AN E6 (MECHANICAL ERROR) MESSAGE. PATIENT REPORTED THE BATTERY IS NEW AND THAT HE TRIED DIFFERENT BATTERIES AS WELL. PATIENT STATED THE DISPLAY ON THE INFUSION DEVICE IS NOT SHOWING. PATIENT REPORTED THE TOP HALF ALL THE WAY ACROSS IS MISSING; THIS AFFECTS THE INSULIN AMOUNT AREA. PATIENT STATED ALL OF THIS OCCURRED ON (B)(6) 2011 IN A ROW. PATIENT SWITCHED TO HIS BACKUP INFUSION DEVICE. PATIENT REPORTED HE WAS ABLE TO TREAT HIMSELF BY BOLUSING AND HIS BLOOD GLUCOSE IS NOW BACK TO NORMAL. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    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 49 YR INSULIN| INSULIN INFUSION SET