BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND ® TEST STRIPS

    MDR report key: 8362629 · Received February 22, 2019

    Report

    Report Number
    1823260-2019-00761
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    February 5, 2019
    Report Date
    April 5, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K952875
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT¿S METER WAS RETURNED FOR INVESTIGATION. THE RETURNED PRODUCT WAS MEASURED IN COMPARISON TO RETENTION MATERIAL. THE MEAN OF THE CONTROL MEASUREMENTS WITH CUSTOMER INSTRUMENT IS AS FOLLOWS: GKL 60: 80,7 MG/DL, GKL 180: 202,3 MG/DL . THE MEAN OF THE MEASUREMENTS WITH EDTA BLOODS ON CUSTOMER INSTRUMENT IS AS FOLLOWS: BLOOD 1: 88,7 MG/DL, BLOOD 2: 71 MG/DL , BLOOD 3: 152 MG/DL. THE MEAN OF THE CONTROL MEASUREMENTS WITH RETENTION INSTRUMENT IS AS FOLLOWS: GKL 60: 80,3 MG/DL, GKL 180: 202,7 MG/DL . THE MEAN OF THE MEASUREMENTS WITH EDTA BLOODS ON RETENTION INSTRUMENT IS AS FOLLOWS: BLOOD 1: 93 MG/DL, BLOOD 2: 71,7 MG/DL, BLOOD 3: 156,3 MG/DL . THE MEAN OF THE MEASUREMENTS WITH EDTA BLOODS ON COBAS C 501 WAS: BLOOD 1: 82,6 MG/DL, BLOOD 2: 70,8 MG/DL, BLOOD 3: 156,2 MG/DL. ALL MEASUREMENTS ON THE CUSTOMER INSTRUMENT AND ON THE REFERENCE INSTRUMENT ARE WITHIN THE CONTROL RANGES. NO SIGNIFICANT DIFFERENCES BETWEEN THE CUSTOMER INSTRUMENT AND RETENTION INSTRUMENT COULD BE OBSERVED WITH THE THREE EDTA BLOODS. THERE ARE NO SIGNIFICANT DIFFERENCES BETWEEN BOTH ACCUTREND DEVICES (CUSTOMER AND REFERENCE) TO THE LABORATORY METHOD. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE NURSE COMPLAINED OF QUESTIONABLE GLUCOSE RESULTS FOR 2 PATIENTS FROM TWO ACCUTREND PLUS METERS. FOR PATIENT 1 ON APPROXIMATELY (B)(6) 2019, THE INITIAL GLUCOSE RESULT WAS PROVIDED AS APPROXIMATELY 50 MG/DL. THE REPEAT GLUCOSE RESULT WITHIN 10 MINUTES WITH THE SAME FINGERSTICK WAS PROVIDED AS APPROXIMATELY 150 MG/DL. THE SPECIFIC RESULTS, METER SERIAL NUMBER, AND DATE AND TIME OF THE MEASUREMENTS WERE ASKED FOR BUT NOT PROVIDED. FOR PATIENT 2 ON (B)(6) 2019 THE INITIAL GLUCOSE RESULT FROM METER SERIAL NUMBER (B)(4) WAS 123 MG/DL. PATIENT 2 HAD BEEN VERY SICK WITH HYPERGLYCEMIC SYMPTOM VOMITING AND HAD NOT BEEN EATING. A LABORATORY SAMPLE WAS COLLECTED WITHIN 10 MINUTES OF THE METER RESULT. ON (B)(6) 2019 THE RESULT FROM THE LABORATORY WAS PROVIDED AS GREATER THAN APPROXIMATELY 500 MG/DL. THE SPECIFIC LABORATORY RESULT WAS ASKED FOR BUT NOT PROVIDED. THE PATIENT'S INSULIN DOSE WAS ADJUSTED BASED ON THE LABORATORY RESULT. ON (B)(6) 2019 THE PATIENT WAS "DOING BETTER". PATIENT 2 WAS A (B)(6) FEMALE WITH A DATE OF BIRTH OF (B)(6) AND WEIGHED (B)(6). THERE WAS NO ADVERSE EVENT. THE DEVICE WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE NURSE STATED THAT THEY HAD BEEN HAVING ISSUES WITH QC CONSISTENTLY BEING ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155434 ACCUTREND ® TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA 28919404

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT 2: AMLODIPINE| PATIENT 2: HUMALOG| PATIENT 2: INSULIN| PATIENT 2: LANTIS| PATIENT 2: LISINOPRIL| PATIENT 2: METFORMIN| PATIENT 2: AMLODIPINE| PATIENT 2: HUMALOG| PATIENT 2: INSULIN| PATIENT 2: LANTIS| PATIENT 2: LISINOPRIL| PATIENT 2: METFORMIN