BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND PLUS GLUCOSE STRIPS

    MDR report key: 5936346 · Received September 8, 2016

    Report

    Report Number
    1823260-2016-01332
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    August 19, 2016
    Report Date
    September 27, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K051376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS WERE RETURNED. RETENTION ACCUTREND GLUCOSE STRIP LOT 137690-00 AND CUSTOMER'S ACCUTREND GLUCOSE STRIP LOT 137690-05 WERE MEASURED WITH TWO EDTA SAMPLES ON CUSTOMER'S METER AND THE RETENTION METERS USED AT THE INVESTIGATION SITE COMPARED TO A COBAS C501 LABORATORY ANALYZER. RETENTION TEST STRIPS WERE ALSO MEASURED WITH CONTROL SOLUTIONS (GKL 60 LOT 600563-99 /GKL180 LOT 600562-99) ON CUSTOMER METER AND THE RETENTION METERS USED AT THE INVESTIGATION SITE. ALL RESULTS WERE WITHIN THE ACCEPTABLE RANGES. THE MATERIAL INVESTIGATED IS WORKING ACCORDING TO THE SPECIFICATIONS. THE RETURNED MATERIAL CAN BE RULED OUT AS A ROOT CAUSE OF THE ERRONEOUS RESULTS. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. THE MOST LIKELY ROOT CAUSE IS A HANDLING ERROR BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED LOW GLUCOSE RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS TESTED WITH AN ACCUTREND PLUS METER WITH SERIAL NUMBER (B)(4) IN A PHARMACY. THE CUSTOMER PROVIDED ERRONEOUS RESULTS FOR 1 PATIENT. IT WAS NOTED THAT THE INSTRUMENT IS USED BY A NON-PROFIT ORGANIZATION THAT PERFORMS OCCASIONAL SCREENINGS TO THE POPULATION. THE INITIAL TEST FROM THE ACCUTREND PLUS METER WAS 66 MG/DL. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS RE-TESTED WITH AN UNSPECIFIED POINT OF CARE DEVICE AND THE RESULT WAS 127 MG/DL. THESE RESULTS WERE OBTAINED 1 HOUR AFTER EATING A SWEET. A DIFFERENT PATIENT WAS TESTED ON THE ACCU-TREND PLUS METER AND THE RESULT WAS 47 MG/DL. THIS PATIENT WAS ASYMPTOMATIC AS WELL. NO OTHER TEST RESULTS WERE PROVIDED. NO ADVERSE EVENT OCCURRED. THE SUSPECT PRODUCT WAS REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587354 ACCUTREND PLUS GLUCOSE STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA 137690-05

    Patients

    Seq Age Sex Outcome Treatment
    1