BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4451481 · Received January 22, 2015

    Report

    Report Number
    1052693-2015-00046
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 27, 2014
    Report Date
    December 7, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. CORRECTION OF 510(K) K090495.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT FOR HIGH BLOOD RESULTS. THE CUSTOMER STORES THEIR SUPPLIES IN THE ORIGINAL VIAL AND CONFIRMS THAT THE VIAL IS KEPT CLOSED AT ALL TIMES AT ROOM TEMPERATURE IN THEIR LIVING ROOM. ASSISTED THE CUSTOMER WITH A BACK TO BACK BLOOD TEST, 363MG/DL 7:45PM (B)(6) AND 279MG/DL 7:46PM (B)(6). EXPECTED BLOOD RESULTS RANGES FROM 120MG/DL OR BELOW- FASTING. THE CUSTOMER WAS UNABLE TO ACCESS THEIR METERS MEMORY. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT FOR HIGH BLOOD RESULTS. THE CUSTOMER STORES THEIR SUPPLIES IN THE ORIGINAL VIAL AND CONFIRMS THAT THE VIAL IS KEPT CLOSED AT ALL TIMES AT ROOM TEMPERATURE IN THEIR LIVING ROOM. ASSISTED THE CUSTOMER WITH A BACK TO BACK BLOOD TEST, 363MG/DL 7:45PM (B)(6) AND 279MG/DL 7:46PM (B)(6). EXPECTED BLOOD RESULTS RANGES FROM 120MG/DL OR BELOW- FASTING. THE CUSTOMER WAS UNABLE TO ACCESS THEIR METERS MEMORY. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52986 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BR4473

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR