BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4688747 · Received April 9, 2015

    Report

    Report Number
    1052693-2015-00408
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 15, 2015
    Report Date
    April 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE, OR USER REUSED TEST STRIP, OR USER'S TEST STRIP HAD POOR FILL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULT. EXPECTED BLOOD GLUCOSE RESULTS NOT FASTING RANGE FROM 100 TO 110 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED DURING CALL REFUSED. VERIFIED STORAGE OF TEST STRIPS IS WITHIN SPECIFICATION SINCE THEY ARE KEPT IN LIVING AREA. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/15/2017 AND OPEN VIAL DATE IS ABOUT 1 TO 2 WEEKS AGO. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: 69MG/DL, (B)(6) 2014, 09:20:00 PM, NOT FASTING; 69MG/DL, (B)(6) 2014, 06:25:00 AM, FASTING; 107MG/DL, (B)(6) 2014, 05:44:00 AM, FASTING; 80MG/DL, (B)(6) 2014, 12:28:00 PM, NOT FASTING; 75MG/DL, (B)(6) 2014, 06:20:00 PM, NOT FASTING. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233546 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2133

    Patients

    Seq Age Sex Outcome Treatment
    1