BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1893949 · Received November 3, 2010

    Report

    Report Number
    2183996-2010-02214
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    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 Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT NOTICED THE INFUSION LUER LOCK WAS CRACKED AND WAS LEAKING INSULIN. BLOOD GLUCOSE WAS ELEVATED WHEN PATIENT CAME HOME FROM SCHOOL. LEVEL OF BLOOD GLUCOSE AND TARGET BLOOD GLUCOSE WERE NOT PROVIDED. PATIENT SELF-TREATED ELEVATED BLOOD GLUCOSE BY CHANGING THE INFUSION SET. THE SECOND INFUSION NEEDLE DID NOT LOCK IN PLACE WHEN IT WAS PRESSED. PATIENT TRIED A THIRD INFUSION SET AND THAT SET WORKED AS INTENDED. INFUSION SETS WERE REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION 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 GWX039

    Patients

    Seq Age Sex Outcome Treatment
    1 INFUSION DEVICE| INSULIN