BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4690394 · Received April 9, 2015

    Report

    Report Number
    1052693-2015-00422
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 18, 2015
    Report Date
    April 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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: USER HAD INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER FEELS WELL AND REQUIRES NO MEDICAL ATTN. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-130 MG/DL. VERIFIED THE STRIPS EXPIRED 10/31/2016 AND HAVE NOT BEEN IN USE FOR FORE THAN 4 MONTHS. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST, 250 MG/DL AND 304 MG/DL. REVIEWED METER MEMORY: 205 MG/DL, (B)(6) 2015, 11:39:00 PM, FASTING: YES; 227 MG/DL, (B)(6) 2015, 11:56:00 PM, FASTING: YES; 218 MG/DL, (B)(6) 2015, 11:55:00 PM, FASTING: YES; 351 MG/DL, (B)(6) 2015, 07:36:00 AM, FASTING: NO; 201 MG/DL, (B)(6) 2015, 11:30:00 PM, FASTING: NO. METER HAS INCORRECT TIME AND DATE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233655 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BR4552

    Patients

    Seq Age Sex Outcome Treatment
    1