BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4701998 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00549
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 23, 2015
    Report Date
    April 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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 STATES THAT SHE FEELS WELL AND REQUIRED NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-130 MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2016. CUSTOMER CONFIRMS THE STRIPS WERE STORED PROPERLY AND WERE FIRST OPENED 03/22/2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 255 MG/DL AND 327MG/DL NOT FASTING, CUSTOMER ATE 1 HOUR AGO. REVIEWED METER MEMORY: 203MG/DL, (B)(6) 2015, 03:56:00 PM, FASTING: YES. 221MG/DL, (B)(6) 2015, 03:54:00 PM, FASTING: YES. 281MG/DL, (B)(6) 2015, 03:51:00 PM, FASTING: YES. 301MG/DL, (B)(6) 2015, 03:48:00 PM, FASTING: YES. 230MG/DL, (B)(6) 2015, 03:40:00 PM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252548 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BR4514

    Patients

    Seq Age Sex Outcome Treatment
    1