BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4792507 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00661
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 4, 2015
    Report Date
    April 27, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: USER HAD AN INACCURATE REFERENCE OR USER'S TEST STRIP HAD POOR STORAGE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NON-FASTING RANGES FROM 49 TO 244MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NOT ABLE TO BE PERFORMED DURING CALL SINCE TEST STRIPS DO NOT HAVE PROPER STORAGE. VERIFIED STORAGE OF TEST STRIPS IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/22/2017 AND OPEN VIAL DATE IS MONTH OF (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 73MG/DL, (B)(6) 2015, 07:12AM; 47MG/DL, (B)(6) 2015, 11:18AM; 49MG/DL, (B)(6) 2015, 12:00AM; 110MG/DL, (B)(6) 2015, 10:41AM; 41MG/DL, (B)(6) 2015, 07:08AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280865 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2139

    Patients

    Seq Age Sex Outcome Treatment
    1