BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2926445 · Received January 14, 2013

    Report

    Report Number
    2183996-2012-02092
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    August 1, 2025
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE LOT IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPLICATED. NO CORRECTIVE ACTIONS WILL BE INITIATED.

    Description of Event or Problem · 1

    ON (B)(4) 2012, THE PT REPORTED, WHILE SHE WAS AT WORK, SHE STARTED TO FEEL REALLY SICK AND NAUSEATED. WHEN SHE GOT HOME HER BLOOD GLUCOSE LEVEL WAS 576 MG/DL. THE PT CHANGED ALL THE ACCESSORIES ON THE INFUSION DEVICE AND HER BLOOD GLUCOSE LEVELS CONTINUED TO BE ELEVATED. THE PT NOTICED THAT THE LAST TWO INFUSION SETS SHE REMOVED HAD BENT CANNULAS WHEN SHE REMOVED THEM FROM THE INFUSION SITE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS NOT REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19917 ACCU-CHEK FLEXLINK PLUS Pump, infusion, insulin LZG ROCHE HEALTH SOLUTIONS INC NA 4790388

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES| RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP