BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4702047 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00517
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 18, 2015
    Report Date
    April 14, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 OF MALFUNCTION: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULT. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 90 TO 100 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. COMPARING RESULTS TO METER AT DOCTOR'S OFFICE AND RECEIVED "LO" WITH TRUERESULT METER AND 104 MG/DL WITH DOCTOR'S METER. BLOOD TEST PERFORMED DURING CALL NOT FASTING ((B)(6) 2015) WITH RESULT OF 108 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (DATE/TIME NOT SET CORRECTLY) : MEMORY 1: 75MG/DL; 03/18/2015; 05:58AM, MEMORY 2: 70MG/DL; 03/18/2015; 05:57AM, MEMORY 3: 79MG/DL; 03/18/2015; 05:56AM, MEMORY 4: 138MG/DL; 03/18/2015; 05:38AM, MEMORY 5: "LO"; 03/17/2015; 05:40AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252663 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2151

    Patients

    Seq Age Sex Outcome Treatment
    1