BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 3971405 · Received July 31, 2014

    Report

    Report Number
    1823260-2014-05761
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HE NOTES A "SLIGHT" LEAK AFTER USING AN INFUSION SET FOR TWO OR THREE DAYS. AT 11:30 AM HE OBTAINED A BLOOD GLUCOSE RESULT OF 26 MMOL/L AND ADMINISTERED 13 UNITS OF INSULIN VIA HIS INSULIN PUMP. HE NOTED INSULIN SOAKED THE ADHESIVE PAD. HE WENT TO HIS CAR, CHANGED HIS INFUSION SET, AND ADMINISTERED AN ADDITIONAL 15 UNITS OF INSULIN. HE DROVE HOME HOME, "FELT SICK", AND WENT TO A HOSPITAL FOR EVALUATION. HE WAS TREATED WITH A SALINE DRIP AND ASSESSED FOR SIGNS OF KETOACIDOSIS FOR THREE HOURS. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION, HOWEVER IT WAS DISCARDED AND UNAVAILABLE FOR RETURN. REPLACEMENT PRODUCT WAS SHIPPED TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448405 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5037901

    Patients

    Seq Age Sex Outcome Treatment
    1 023 YR Required Intervention PERFORMA COMBO BLOOD GLUCOSE MONITOR