BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FASTCLIX

    MDR report key: 19722351 · Received July 10, 2024

    Report

    Report Number
    MW5157211
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    January 13, 2024
    Report Date
    July 8, 2024
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FOLLOWING MY DOCTOR'S APPOINTMENT, THE DOCTOR INSTRUCTED ME TO CHECK MY SUGAR AND LOG MY RESULTS. I FILLED MY ORDER WITH (B)(6) ON (B)(6) 2024 AND STARTED USING THE PRODUCT ON (B)(6) 2024. AFTER I PRICKED MY FINGER, I NOTICED MY FINGER BEGAN TO TURN RED AND SWOLLEN PAIN AT THE INJECTION SITE, FOLLOWED BY A FEVER. I COULDN'T FIGURE OUT THE CAUSE OF MY PROBLEM, IT JUST HAPPENED EVERY TIME I CHECKED MY BLOOD SUGAR. BECAUSE I WAS NEW TO CHECKING MY SUGAR, I THOUGHT THESE WERE THE NORMAL SIDE EFFECTS OF THE LANCET. THERE WERE DAYS WHEN I FELT ILL WITH MILD SYMPTOMS RANGING FROM FEVER TO SEVERE HEADACHE AND VOMITING INCLUDING MY FINGER TURNING BLACK. AFTER I USED TWO FILLED BOXES OF FASTCLIX, I DECIDED TO DISCONTINUE THE PRODUCT ENTIRELY AND JUST STARTED INSULIN WITH NO RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386366 ACCU-CHEK FASTCLIX MULTIPLE USE BLOOD LANCET FOR SINGLE PATIENT USE ONLY QRL ROCHE DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other ASPIRIN.| DICLOFFENAC SODIUM 75MG.| GABAPENTIN 300MG.| HYDROCODONE.| LOVASTATIN.| METOPROLOL TARTRATE.