BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND PLUS GLUCOSE STRIPS

    MDR report key: 10378007 · Received August 7, 2020

    Report

    Report Number
    1823260-2020-01915
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    June 21, 2020
    Report Date
    August 7, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K051376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER'S METERS AND STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. RETENTION SAMPLES GLUCOSE LOT 37996005 WERE MEASURED WITH CONTROLS GKL 60 LOT 346092-99 /GKL 180 LOT 346093-99 AND 3 EDTA BLOOD ON REFERENCE DEVICES COMPARED TO LABORATORY METHOD. RANGES CONTROL SOLUTIONS: RANGE GKL 60: 58 ¿ 98 MG/DL INVESTIGATION RESULTS USING RETENTION MATERIAL: QC 1: 82 MG/DL, QC 2: 74 MG/DL, QC 3: 75 MG/DL. INVESTIGATION RESULTS USING RETENTION MATERIAL: RANGE GKL 180: 173 ¿ 232 MG/DL QC 1: 200 MG/DL, QC 2: 192 MG/DL, QC 3: 204 MG/DL. ALL RESULTS WERE WITHIN THE CONTROL RANGE. NO SIGNIFICANT DIFFERENCES TO THE LABORATORY METHOD. OCCUPATION IS LAY USER/PATIENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE RESULTS USING AN ACCUTREND PLUS METER WHEN COMPARED TO AN ACCU-CHEK INSTANT METER. THE METER RESULT ON THE ACCUTREND METER WAS 52 MG/DL. A FEW MINUTES LATER, THE CUSTOMER TESTED ON THE ACCU-CHEK INSTANT METER. THE RESULT WAS 104 MG/DL. THE ACCU-CHEK INSTANT AND ACCUTREND METER'S SERIAL NUMBERS WERE REQUESTED BUT NOT PROVIDED. IT IS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER'S NORMAL GLUCOSE RANGE IS 100-110 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843304 ACCUTREND PLUS GLUCOSE STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA 37996005

    Patients

    Seq Age Sex Outcome Treatment
    1