BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND PLUS GLUCOSE STRIPS

    MDR report key: 10696224 · Received October 19, 2020

    Report

    Report Number
    1823260-2020-02573
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    September 25, 2020
    Report Date
    November 12, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K051376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SAMPLES AND RETENTION SAMPLES GLUCOSE LOT 37996005 WERE MEASURED WITH CONTROLS GKL 60 LOT 346092-99 /GKL 180 LOT 346093-99 AND 2 EDTA BLOOD ON CUSTOMER DEVICE AND REFERENCE DEVICES COMPARED TO LABORATORY METHOD. RESULTS: THE MEAN OF THE MEASUREMENTS WITH RETURNED SAMPLES GLUCOSE LOT 37996005 TEST STRIPS AND 1ST EDTA BLOOD SAMPLE IS AS FOLLOWS: - CUSTOMER INSTRUMENT: 82.9MG/DL - RETENTION INSTRUMENT: 88 MG/DL THE MEAN OF THE MEASUREMENTS WITH RETURNED SAMPLES GLUCOSE LOT 37996005 TEST STRIPS AND 2ND EDTA BLOOD SAMPLE IS AS FOLLOWS: - CUSTOMER INSTRUMENT: 140.5 MG/DL - RETENTION INSTRUMENT: 136 MG/DL THE MEAN OF THE MEASUREMENTS WITH RETENTION SAMPLES GLUCOSE LOT 37996005 TEST STRIPS AND 1ST EDTA BLOOD SAMPLE IS AS FOLLOWS: - CUSTOMER INSTRUMENT: 85.9 MG/DL - RETENTION INSTRUMENT: 84.7 MG/DL THE MEAN OF THE MEASUREMENTS WITH RETENTION SAMPLES GLUCOSE LOT 37996005 TEST STRIPS AND 2ND EDTA BLOOD SAMPLE IS AS FOLLOWS: - CUSTOMER INSTRUMENT: 136.3 MG/DL - RETENTION INSTRUMENT: 135.7 MG/DL THE MEAN OF THE MEASUREMENTS WITH CONTROL SOLUTION GKL60 WITH RETENTION TEST STRIPS IS AS FOLLOWS: - CUSTOMER INSTRUMENT: 4.2 MMOL/L - RETENTION INSTRUMENT: 78.7 MG/DL THE MEAN OF THE MEASUREMENTS WITH CONTROL SOLUTION GKL180 WITH RETENTION TEST STRIPS IS AS FOLLOWS: - CUSTOMER INSTRUMENT: 10.7 MMMOL/L - RETENTION INSTRUMENT: 196 MG/D RANGES GLU CONTROL SOLUTIONS: RANGE GKL60: 3.2 - 5.4 MMOL/L 58-98 MG/DL RANGE GKL180: 9.5 - 12.9 MMOL/L 172 ¿ 232 MMOL/L THE MEAN OF THE MEASUREMENTS WITH LABORATORY METHOD (COBAS) IS AS FOLLOWS: - BLOOD 1: 81.7 MG/DL - BLOOD 2: 133.4 MG/DL ALL MEASUREMENTS WITH RETENTION TEST STRIPS ON THE REFERENCE INSTRUMENT AND THE CUSTOMER INSTRUMENT ARE WITHIN THE CONTROL RANGES. NO PRODUCT PROBLEM WAS FOUND. MEDWATCH FIELDS D9 AND H3 WERE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). OCCUPATION IS LAY USER/PATIENT. THE REPORTER CONFIRMED QC WAS ACCEPTABLE. AFTER METER TESTING, THE REPORTER DID NOT PERFORM A PLAUSIBILITY CHECK. PER PRODUCT LABELING, "PLAUSIBILITY CHECK AFTER GLUCOSE MEASUREMENT: REMOVE THE TEST STRIP AND TURN IT WITH THE BOTTOM SIDE UPWARDS. COMPARE THE REACTION AREA ON THE BOTTOM SIDE OF THE STRIP WITH THE COLOR FIELD SCALE ON THE LABEL OF THE TEST STRIP CONTAINER. THE COLOR OF THE REACTION AREA MUST APPROXIMATELY MATCH THE COLOR ASSIGNED TO YOUR MEASUREMENT RESULT. IF THERE IS A GREAT DEVIATION, PERFORM A METER FUNCTION CHECK." THE REPORTER'S TEST STRIPS AND METER WERE REQUESTED FOR RETURN. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME AND IS NOT EXPECTED TO BE RETURNED. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS WITH AN ACCUTREND PLUS METER SERIAL NUMBER (B)(4) COMPARED TO TWO ACCU-CHEK AVIVA METERS. THE REPORTER PERFORMED SIDE BY SIDE METER COMPARISON TESTING WITH THE ACCUTREND PLUS METER AND TWO ACCU-CHEK AVIVA METERS. DURING COMPARISON TESTING, THE REPORTERS "BLOOD WAS APPLIED ON ONE STRIP FIRST, THEN ON THE OTHER STRIP STRAIGHT AFTER." THE REPORTER CONFIRMED THE TEST STRIPS USED FOR COMPARISON TESTING WERE VISUALLY OK. THE REPORTER'S GLUCOSE RESULT WITH THE ACCUTREND PLUS METER WAS 2.8 MMOL/L. THE REPORTER'S GLUCOSE RESULT WITH AN ACCU-CHEK AVIVA WAS 5.2 MMOL/L. THE REPORTER'S GLUCOSE RESULT WITH ANOTHER ACCU-CHEK AVIVA WAS "5.2 OR 5.3 MMOL/L."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166449 ACCUTREND PLUS GLUCOSE STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA 37996005

    Patients

    Seq Age Sex Outcome Treatment
    1