BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2073004 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01147
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE FOR THE PAST MONTH AND INSULIN LEAKAGE WHILE USING THE INFUSION SETS. SHE STATED LAST NIGHT 4-4.5 HOURS AFTER DINNER HER BLOOD GLUCOSE MEASURED 298 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 120-170 MG/DL. SHE EITHER BOLUSES THROUGH THE INFUSION DEVICE OR INJECTS INSULIN VIA SYRINGE TO LOWER HER BLOOD GLUCOSE. HER BLOOD GLUCOSE ELEVATES WITHIN A COUPLE OF HOURS AFTER INSERTING THE INFUSION SET. SHE STATED, THE INFUSION SET CANNULA HAS BEEN BENT A COUPLE OF TIMES AND SHE NOTICES INSULIN LEAKAGE WHEN HER CLOTHES BECOME WET. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS NOT AVAILABLE FOR RETURN. NO PRODUCT WILL BE RETURNED FOR EVAL.

    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 60 YR INSULIN| INSULIN INFUSION PUMP