BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2253743 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02199
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 21, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED EXPERIENCING ELEVATED READINGS WITH HIS INFUSION DEVICE. PT STATED HE HAS HAD ELEVATED BLOOD GLUCOSE READINGS FOR ABOUT 4 DAYS. PT REPORTED HIS BLOOD GLUCOSE READINGS GOT AS HIGH AS 400 MG/DL. PT'S TARGET BLOOD GLUCOSE RANGE IS AROUND 140-150 MG/DL. PT STATED THE INSULIN IS NOT AT ROOM TEMPERATURE WHEN FILLING THE INSULIN CARTRIDGE. ADVISED PT TO ALLOW THE INSULIN TO WARM TO ROOM TEMPERATURE. PT REPORTED HIS BLOOD GLUCOSE HAS RETURNED TO NORMAL. ON F/U CALL ON (B)(6) 2011, PT REPORTED HIS BLOOD GLUCOSE READINGS HAVE BEEN FINE SINCE HE STARTED USING THE BACKUP INFUSION DEVICE. VERIFIED SETTINGS AND TOTAL ARE THE SAME. REQUESTED PT TO SWITCH BACK TO PRIMARY INFUSION DEVICE WITH THE SAME ACCESSORIES. ON F/U CALL ON (B)(6) 2011, PT REPORTED HE SWITCHED TO THE PRIMARY INFUSION DEVICE AND EXPERIENCED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS PROBABLY MIDWAY THROUGH THE DAY. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 38 YR INSULIN INFUSION SET| INSULIN