BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4999097 · Received August 6, 2015

    Report

    Report Number
    1052693-2015-01366
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 13, 2015
    Report Date
    December 9, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET EVALUATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER'S TEST STRIP HAD POOR STORAGE INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. ADDITIONAL PRODUCT CODES ADDED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMERWIFE STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMEREXPECTED BLOOD RESULTS ARE 95-105MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 02/28/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WAS FIRST OPENED (B)(6) 2015. 1: 146MG/DL, (B)(6) 2015, 12:13PM, FASTING: YES; 2. 85MG/DL, (B)(6) 2015, 03:56AM, FASTING: YES; 3: 84MG/DL, (B)(6) 2015, 04:10AM, FASTING: YES; 4: 59MG/DL, (B)(6) 2015, 04:53AM, FASTING: YES; 5: 55MG/DL, (B)(6) 2015, 04:53AM, FASTING: YES. CUSTOMER'S CONCERN: 55MG/DL, (B)(6) 2015, 04:53AM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMER'S WIFE STATES THAT HER FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 95-105MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 02/28/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WAS FIRST OPENED (B)(6) 2015. (B)(6). FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520411 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2231

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR