BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 883879 · Received July 20, 2007

    Report

    Report Number
    2183996-2007-01046
    Event Type
    Injury
    Date Received
    July 20, 2007
    Date of Event
    May 25, 2007
    Report Date
    July 12, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K033892
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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. ACCU-CHECK FLEXLINK IS SAME PRODUCT AS ACCU-CHECK ULTRAFLEX WHICH IS SOLD IN THE US UNDER 510 (K) # K033892.

    Description of Event or Problem · 1

    THE PT STATED THAT APPROX 2 MONTHS AGO, HER BLOOD GLUCOSE ELEVATED TO 300 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS AROUND 150MG/DL. SHE STATED THAT HER INFUSION SET HAD BEEN IN USE FOR 2-3 HOURS. SHE WAS ABLE TO LOWER HER BLOOD GLUCOSE BY CHANGING HER INFUSION SET AND BOLUSING THROUGH HER INFUSION DEVICE. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. ACCU-CHEK FLEXLINK 7B059UF

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention INSULIN| INSULIN INFUSION PUMP