BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4824660 · Received June 4, 2015

    Report

    Report Number
    1052693-2015-00850
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 8, 2015
    Report Date
    December 17, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 HAD AN INACCURATE REFERENCE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER'S CAREGIVER STATES THAT THE PATIENT FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S' EXPECTED BLOOD RESULTS ARE 78-120 MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 10/31/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED 1 MONTH AGO. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 457 MG/DL AND 471 MG/DL FASTING. REVIEWED METER MEMORY: 1:322MG/DL, (B)(6) 2015, 04:39:00 AM FASTING: YES. 2:571MG/DL, (B)(6) 2015, 04:40:00 PM FASTING: YES. 3:422MG/DL, (B)(6) 2015, 03:08:00 PM FASTING: YES. 4:243MG/DL, (B)(6) 2015, 04:19:00 AM FASTING: YES. 5:429MG/DL, (B)(6) 2015, 04:52:00 PM FASTING: YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER'S CAREGIVER STATES THAT THE PATIENT FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 78-120MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 10/31/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED 1 MONTH AGO. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 457MG/DL AND 471MG/DL FASTING. REVIEWED METER MEMORY: 1:322MG/DLMG/DL (B)(6) 2015 04:39:00 AM FASTING:YES. 2:571MG/DLMG/DL (B)(6) 2015 04:40:00 PM FASTING:YES. 3:422MG/DLMG/DL (B)(6) 2015 03:08:00 PM FASTING:YES. 4:243MG/DLMG/DL (B)(6) 2015 04:19:00 AM FASTING:YES. 5:429MG/DLMG/DL (B)(6) 2015 04:52:00 PM FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363616 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BR4552

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR