BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070411 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01102
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    October 1, 2010
    Report Date
    March 23, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1492-2011
    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. 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 EXPERIENCED ELEVATED BLOOD GLUCOSE OF AT LEAST 20 MMOL/L (360 MG/DL) EVERY-OTHER DAY WHEN USING THE INFUSION SETS, AND PHYSICIAN THOUGHT THE INFUSION CANNULAS WERE NOT INSERTED PROPERLY. BLOOD GLUCOSE ELEVATED WITHIN 24 HOURS OF INSERTION. THE INFUSION SET CAUSED BRUISING AND THERE WERE RAISED, RED LUMPS NEAR THE INFUSION SITES. NOTHING UNEXPECTED OCCURRED DURING PREPARATION OF THE INFUSION SET. PT FOUND IT MORE UNCOMFORTABLE TO INSERT THE HEADSETS, AND IT WAS REPORTED THAT CONNECTION BETWEEN THE TUBING AND HEADSETS WAS NOT VERY SECURE. THE INFUSION CANNULAS DID NOT KINK. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. PT STOPPED USING THIS TYPE OF INFUSION SET A FEW MONTHS PRIOR TO THE REPORT. INFUSION SETS WERE REQUESTED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION DEVICE| INSULIN