BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2253000 · Received August 31, 2011

    Report

    Report Number
    2183996-2011-02367
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 22, 2010
    Report Date
    August 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE EXPERIENCED "SERIOUS HEALTH PROBLEMS" 3 TIMES OVER THE PAST YEAR WHILE USING THE INFUSION SETS. THIS LAST OCCURRED 1.5 MONTHS AGO. PT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 600 MG/DL AND DID NOT FEEL WELL, AND SHE HAD A HEADACHE AND FELT FAINT. NORMAL BLOOD GLUCOSE IS 100-150 MG/DL. PT REMOVED THE INFUSION HEADSET AND NOTICED THE CANNULA WAS KINKED IN THE MIDDLE. PT INSERTED A NEW HEADSET AND WAS THEN "FINE." DURING EACH EVENT, BLOOD GLUCOSE ELEVATED AND PT FOUND THE CANNULA WAS KINKED. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PT WAS ADVISED TO STOP USING THIS PRODUCT. INFUSION SETS WERE REQUESTED FOR EVALUATION. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX016

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION DEVICE