BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2002139 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00119
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED BLOOD GLUCOSE ELEVATED TO 580 MG/DL AFTER STARTING A NEW TYPE OF INFUSION SET. THERE WAS ALSO INSULIN LEAKING FROM HIS INFUSION SITE. HE ATTEMPTED TO LOWER HIS BLOOD GLUCOSE BY DELIVERING A CORRECTION BOLUS. THE NIGHT BEFORE THE REPORT, HE LOOKED AT HIS SITE AND NOTICED INSULIN LEAKING AROUND IT. INFUSION SET WAS REMOVED, AND THE CANNULA WAS NOT PROPERLY INSERTED INTO HIS BODY. THE CANNULA WAS FLAT AGAINST HIS STOMACH. HE CHANGED THE INFUSION SET AND AGAIN NOTICED LEAKING ON THE DAY OF THE REPORT. HE COULD NOT DETERMINE THE SOURCE OF THE LEAK THAT TIME. PT CHANGED HIS INFUSION SET DURING THE TROUBLESHOOTING CALL, AND THERE WAS NO FURTHER LEAKING. COMPLIMENTARY INSERTION DEVICE WAS SENT. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVAL. F/U WAS COMPLETED WITH FATHER ON (B)(6) 2011. PT WAS UNAVAILABLE, BUT FATHER REPORTED NO FURTHER ISSUES WITH THE INFUSION SETS. NORMAL BLOOD GLUCOSE WAS NOT PROVIDED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA GWX053

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR INSULIN| INSULIN INFUSION DEVICE