BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080235 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00836
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    PT REPORTED THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE DUE TO THE INFUSION SETS IN THE MIDDLE OF (B)(6) 2011. THIS OCCURRED AT HER WORK PLACE. PT FELT NOT ENOUGH INSULIN WAS DELIVERED TO HER BODY, AND SHE EXPERIENCED NAUSEA, DRY MOUTH, AND HEADACHES AS A RESULT. BLOOD GLUCOSE ELEVATED TO 20-28 MMOL/L (360-504 MG/DL). PT'S BLOOD GLUCOSE HAS SINCE STABILIZED. INFUSION SETS WERE REQUESTED FOR EVALUATION. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL DETAILS WERE NOT 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 50 YR INSULIN INFUSION DEVICE| INSULIN