BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 4140753 · Received October 3, 2014

    Report

    Report Number
    1823260-2014-07608
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    May 31, 2014
    Report Date
    December 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER FELT NAUSEATED AND VOMITED ON (B)(6) 2014. HER BLOOD GLUCOSE WAS 21.0 MMOL/L, AND SHE CHANGED THE INFUSION SET AND DELIVERED INSULIN VIA THE INFUSION DEVICE. HER SON FOUND HER UNCONSCIOUS AND CONTACTED THE PARAMEDICS. SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT AND TREATED WITH INTRAVENOUS INSULIN. THE MEDICAL STAFF REMOVED THE INFUSION SET AND NOTICED THE CANNULA WAS BENT. SHE "WOKE UP" ON (B)(6) 2014 AND BEGAN TO USE THE INFUSION DEVICE WITH A DIFFERENT LOT OF INFUSION SETS. AT THIS TIME, HER BLOOD GLUCOSE LEVEL WAS BETTER. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620462 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5041947

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR Hospitalization| R