BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND PLUS GLUCOSE STRIPS

    MDR report key: 10373563 · Received August 6, 2020

    Report

    Report Number
    1823260-2020-01905
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 6, 2020
    Report Date
    August 6, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER'S METERS AND STRIPS WERE REQUESTED FOR INVESTIGATION. THE PRODUCTS HAVE NOT BEEN RECEIVED AT THIS TIME. RETENTION SAMPLES FOR GLUCOSE LOT 349029-04 WERE MEASURED WITH RETENTION CONTROLS GKL60 LOT 346092-99 /GKL180 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: 78 MG/DL, QC 2: 74 MG/DL, QC 3: 72 MG/DL. INVESTIGATION RESULTS USING RETENTION MATERIAL: RANGE GKL 180: 166 ¿ 224 MG/DL, QC 1: 195 MG/DL, QC 2: 194 MG/DL, QC 3: 187 MG/DL. ALL RESULTS WERE WITHIN THE CONTROL RANGE. NO SIGNIFICANT DIFFERENCES TO THE LABORATORY METHOD. 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 ACTIVE METER. THE METER RESULT ON THE ACCUTREND METER WAS 82 MG/DL. A FEW MINUTES LATER, THE CUSTOMER TESTED ON THE ACCU-CHEK ACTIVE METER. THE RESULT WAS 110 MG/DL. THE CUSTOMER PROVIDED TWO ACCUTREND METER SERIAL NUMBERS (B)(4). IT IS UNKNOWN WHICH METER GAVE THE RESULT. THE ACCU-CHEK ACTIVE METER'S SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. IT IS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838850 ACCUTREND PLUS GLUCOSE STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA 34902904

    Patients

    Seq Age Sex Outcome Treatment
    1