BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 5014367 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01477
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 27, 2015
    Report Date
    December 7, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT YET RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAS HIGH GLUCOSE VALUE INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF HI CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION AT THE TIME OF THE CALL, HOWEVER THE CUSTOMER WAS HOSPITALIZED DAYS BEFORE HIGH RESULTS. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 220-350 MG/DL FASTING. VERIFIED THE STRIPS EXPIRE ON (B)(6) 2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 483MG/DL AND 538 MG/DL FASTING. REVIEWED METER MEMORY: 01:538 MG/DL, (B)(6) 2015, 11:10:00 AM, FASTING: YES. 02::483 MG/DL, (B)(6) 2015, 11:12:00 AM, FASTING: YES. 03:547 MG/DL, (B)(6) 2015, 10:00:00 AM, FASTING: YES. 04:507 MG/DL, (B)(6) 2015, 08:00:00 AM, FASTING: YES. 5:HI, (B)(6) 2015, 03:300:00 AM, FASTING: YES. ON SATURDAY HE WENT TO EMERGENCY ROOM DUE TO OTHER MEDICAL ISSUES; HE READ 547 MG/DL WITH OUR METER, AND UPON ARRIVAL HE READ IN THE 600 MG/DL AT THE HOSPITAL AND DISCHARGED THE SAME DAY WITH A GLUCOSE LEVEL IN THE 400 MG/DL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION AT THE TIME OF THE CALL, HOWEVER THE CUSTOMER WAS HOSPITALIZED DAYS BEFORE FOR HIGH RESULTS. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 220-350MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 09/19/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 483MG/DL AND 538MG/DL FASTING. REVIEWED METER MEMORY: (B)(6). ON SATURDAY HE WENT TO EMERGENCY ROOM DUE TO OTHER MEDICAL ISSUES; HE READ 547MG/DL WITH OUR METER, AND UPON ARRIVAL HE READ IN THE 600'S MG/DL AT THE HOSPITAL AND DISCHARGED THE SAME DAY WITH A GLUCOSE LEVEL IN THE 400'S MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532754 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BS4615

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization