BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5014882 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01409
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 17, 2015
    Report Date
    December 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT UNDER EVAL.

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH A DEFECT FOUND. BLACK CHEMISTRY OBSERVED. THE MOST LIKELY UNDERLYING ROOT CAUSE OF THIS MALFUNCTION IS BLACK CHEMISTRY DUE TO IMPROPER STORAGE. ADDITIONAL PRODUCT CODES ADDED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING OF "LO." CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 170-180MG/DL FASTING. VERIFIED THE STRIPS EXPIRE ON 04/28/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, LO AND LO FASTING. REVIEWED METER MEMORY: LO (B)(6) 2008 12:04:00 PM FASTING: YES; LO (B)(6) 2015 08:03:00 AM FASTING: YES. CUSTOMERS CONCERN: ALL ONLY TWO RESULTS STORED ON (B)(6) 2008 AS LO. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 170-180MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/28/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, LO AND LO FASTING. REVIEWED METER MEMORY: LO, (B)(6) 2008, 12:04:00 PM, FASTING:YES; LO, (B)(6) 2015, 08:03:00 AM, FASTING:YES. CUSTOMERS CONCERN: ALL ONLY TWO RESULTS STORED (B)(6) 2008 AS LO. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533175 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1943

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR