BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2172413 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01782
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    THE PATIENT'S HUSBAND REPORTED THAT 3 WEEKS AGO, THE PATIENT'S BLOOD GLUCOSE ELEVATED TO 500 MG/DL. SHE BOLUSED 12 UNITS OF INSULIN AND SHE FOUND HER CLOTHES BECAME WET WITH INSULIN AND THE CANNULA WAS LEAKING. SHE DOES NOT KNOW IF THE HEADSET SELF ADHESIVE WAS WET PRIOR TO THE BOLUS. SHE CHANGED THE HEADSET TO RESOLVE THE ISSUE. ON (B)(6) 2011, HER BLOOD GLUCOSE ELEVATED TO 390 MG/DL AND SHE BOLUSED AND HER CLOTHES BECAME WET WITH INSULIN. BOTH INFUSION SETS WERE FROM THE SAME LOT. HE STATED THAT THE CANNULA SEEMS TO BE HARDER THAN PREVIOUSLY USED INFUSION SETS. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 7490177

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP