BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4792494 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00618
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    March 30, 2012
    Report Date
    April 24, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED FOR EVALUATION: NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE FOR THIS COMPLAINT IS: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". SISTER ((B)(6)) OF CUSTOMER STATES THAT CUSTOMER FEELS WELL AND DOESN'T REQUIRE MEDICAL ATTENTION. VERIFIED THE STRIPS EXPIRE 10/13/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. CUSTOMER DECLINED BLOOD TEST. REVIEWED METER MEMORY: LO MG/DL, (B)(6) 2015, 05:08:53 PM, FASTING: YES; 52MG/DL, (B)(6) 2015, 08:17:00 PM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". SISTER ((B)(6)) OF CUSTOMER STATES THAT CUSTOMER FEELS WELL AND DOESN'T REQUIRE MEDICAL ATTENTION. VERIFIED THE STRIPS EXPIRE 10/13/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. CUSTOMER DECLINED BLOOD TEST. REVIEWED METER MEMORY:. LO, (B)(6) 2015, 05:08:53 PM, FASTING:YES,; 52MG/DL, (B)(6) 2015, 08:17:00 PM ,FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281097 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2199

    Patients

    Seq Age Sex Outcome Treatment
    1