BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2031461 · Received March 18, 2011

    Report

    Report Number
    2183996-2011-00532
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    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, THE PT'S MOTHER REPORTED THE PT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE OF 17.6-18.9 (317-340 MG/DL) SINCE (B)(6) 2011 AND THE INFUSION DEVICE SHUT DOWN WITHOUT WARNING. HER TARGET BLOOD GLUCOSE RANGE IS 4-7 MMOL/L (72-126 MG/DL). TROUBLESHOOTING DID NOT REVEAL THE CAUSE OF ELEVATED BLOOD GLUCOSE. THE PT STATED, THE DISPLAY WAS BLANK THIS MORNING AND A NEW BATTERY WAS INSERTED AND THE INFUSION DEVICE FUNCTIONED NORMALLY. E7 (ELECTRONIC) ERROR WAS DISPLAYED 3 TIMES TODAY. THE PT INJECTED INSULIN VIA SYRINGE TO LOWER HER BLOOD GLUCOSE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR INSULIN| INSULIN INFUSION SET