BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2031258 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00553
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, PT REPORTED, THE INFUSION SET ADHESIVE LOOSENED DURING A BATH A COUPLE OF WEEKS PRIOR TO THE REPORT. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN 24 HOURS, AND SHE PLACED TAPE OVER THE INFUSION SET TO SECURE IT. THE NEXT MORNING, HER BLOOD GLUCOSE WAS ELEVATED TO 300 MG/DL. TARGET BLOOD GLUCOSE IS 70-130 MG/DL. PT TREATED HYPERGLYCEMIA BY CHANGING HER INFUSION SET, AND SHE NOTICED THE INFUSION CANNULA WAS BENT WHEN IT WAS REMOVED. SHE WAS NOT ABLE TO RECALL IF ADD'L TREATMENT WAS NEEDED AS IT DID NOT OCCUR RECENTLY. THE ALLEGED INFUSION SET WAS DISCARDED AND NOT REQUESTED FOR EVAL. PT WAS SENT SAMPLES OF 2 TYPES OF INFUSION SETS TO TRY. 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 GWX190

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN| INSULIN INFUSION DEVICE