BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4792459 · Received April 29, 2015

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    Report

    Report Number
    1052693-2015-00659
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 3, 2015
    Report Date
    December 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAS HIGH GLUCOSE VALUE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "HI" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NOT VERIFIED. CUSTOMER FELLS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NOT PERFORMED DURING CALL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/15/2017 AND OPEN VIRAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: MEMORY 1: 120MG/DL, (B)(6) 2015, 05:04PM; MEMORY 2: "HI", (B)(6) 2015, 04:54PM, MEMORY 3: "HI" (B)(6) 2015, 04:53PM; MEMORY 4: 120MG/DL, (B)(6) 2015, 06:04PM;L MEMORY 5: 84MG/DL, (B)(6) 2015, 08:01PM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "HI" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NOT VERIFIED. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NOT PERFORMED DURING CALL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/15/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: (B)(6). ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281914 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2069

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR