BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND PLUS GLUCOSE STRIPS

    MDR report key: 8440497 · Received March 21, 2019

    Report

    Report Number
    1823260-2019-01156
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 5, 2019
    Report Date
    May 6, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K051376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED METERS AND STRIPS FOR INVESTIGATION. THE CUSTOMER STRIPS AND RETENTION STRIPS WERE MEASURED WITH TWO EDTA BLOOD ON CUSTOMER DEVICES AND REFERENCE DEVICES IN COMPARISON TO LAB METHOD. RANGES CONTROL SOLUTIONS: RANGE GKL 60: 58 ¿ 98 MG/DL (3.2 ¿ 5.4 MMOL/L) . RANGE GKL 180: 160 ¿ 224 MG/DL (9.2 ¿ 12.4 MMOL/L) . RESULTS: THE MEAN OF THE CONTROL MEASUREMENTS GKL 60 WITH RETENTION TEST STRIPS AND CUSTOMER AND RETENTION INSTRUMENTS IS AS FOLLOWS: - RR0296383: 4.17 MMOL/L . - RR0243249: 4.33 MMOL/L . - RETENTION INSTRUMENT: 76 MG/DL. THE MEAN OF THE CONTROL MEASUREMENTS GKL 180 WITH RETENTION TEST STRIPS AND CUSTOMER AND RETENTION INSTRUMENTS IS AS FOLLOWS: - RR0296383: 10.6 MMOL/L. - RR0243249: 10.93 MMOL/L. - RETENTION INSTRUMENT: 202 MG/DL. THE MEAN OF THE MEASUREMENTS WITH EDTA BLOOD 1 ON CUSTOMER INSTRUMENTS AND RETENTION INSTRUMENT WITH CUSTOMER TEST STRIPS IS AS FOLLOWS: - RR0296383: 3.9 MMOL/L (70.26 MG/DL). - RR0243249: 4.2 MMOL/L (75.67 MG/DL). - RETENTION INSTRUMENT: 76 MG/DL. THE MEAN OF THE MEASUREMENTS WITH EDTA BLOOD 1 ON CUSTOMER INSTRUMENTS AND RETENTION INSTRUMENT WITH RETENTION TEST STRIPS IS AS FOLLOWS: - RR0296383: 4.0 MMOL/L (72.06 MG/DL) - RR0243249: 4.23 MMOL/L (76.21 MG/DL) - RETENTION INSTRUMENT: 76,33 MG/DL THE MEAN OF THE MEASUREMENTS WITH EDTA BLOOD 2 ON CUSTOMER INSTRUMENTS AND RETENTION INSTRUMENT WITH CUSTOMER TEST STRIPS IS AS FOLLOWS: - RR0296383: 5.5 MMOL/L (99.09 MG/DL) - RR0243249: 6.1 MMOL/L (109.9 MG/DL) - RETENTION INSTRUMENT: 110 MG/DL THE MEAN OF THE MEASUREMENTS WITH EDTA BLOOD 2 ON CUSTOMER INSTRUMENTS AND RETENTION INSTRUMENT WITH RETENTION TEST STRIPS IS AS FOLLOWS: - RR0296383: 5.9 MMOL/L (106.29 MG/DL) - RR0243249: 5.8 MMOL/L (104.49 MG/DL) - RETENTION INSTRUMENT: 112.67 MG/DL THE RESULTS OF THE MEASUREMENTS WITH EDTA BLOODS ON COBAS C 501 WERE: - BLOOD 1, SAMPLE 1: 71.6 MG/DL - BLOOD 1, SAMPLE 2: 71.8 MG/DL - BLOOD 2, SAMPLE 1: 106.9 MG/DL - BLOOD 2, SAMPLE 2: 104.6 MG/DL THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN ACCUTREND PLUS DEVICES AND TO THE LABORATORY METHOD. ALL RESULTS ARE WITHIN THE TOLERANCE RANGE. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET SPECIFICATIONS. MEDWATCH FIELD D10 AND H3 HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS WHEN TESTING BETWEEN ACCUTREND PLUS METER SERIAL NUMBER (B)(4) (METER A) AND ACCUTREND PLUS METER SERIAL NUMBER (B)(4) (METER B). THE CUSTOMER TESTED ON METER A WITH A RESULT OF 3.7 MMOL/L. THE CUSTOMER TESTED ON METER B WITH A RESULT OF 5.0 MMOL/L. IT IS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER PRICKED HER FINGER AND APPLIED BLOOD TO 2 DIFFERENT TEST STRIPS AND TESTED ON EACH METER AT THE SAME TIME. QC RESULTS HAD PASSED ON BOTH METERS. THE CUSTOMER STATED SHE FILLED THE TEST PAD COMPLETELY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. BOTH METERS AND THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233819 ACCUTREND PLUS GLUCOSE STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA 34902903

    Patients

    Seq Age Sex Outcome Treatment
    1