BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUBALANCE

    MDR report key: 5500476 · Received March 15, 2016

    Report

    Report Number
    1052693-2016-00508
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 22, 2016
    Report Date
    May 31, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:STRIP ISSUE, USER IS TESTING WITH EXPIRED TEST STRIPS. CORRECTION OF SERIAL #: METER SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:STRIP ISSUE, USER IS TESTING WITH EXPIRED TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAIN THAT GOT A 'HI' ON HIS METER READING. CUSTOMER STATES THAT FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 150-170MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 2/19/2012. REVIEWED METER MEMORY: (B)(6). MEMORY CONCERNS:WITH HI. THE CUSTOMER DID NOT REMEMBER WHEN THE STRIPS WERE OPENED, AND STRIPS EXPIRATION DATE (2/19/2012), STRIPS ARE EXPIRED.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAIN THAT GOT A 'HI' ON HIS METER READING. CUSTOMER STATES THAT FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 150-170MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 2/19/2012. REVIEWED METER MEMORY (B)(6). MEMORY CONCERNS:WITH HI. THE CUSTOMER DID NOT REMEMBER WHEN THE STRIPS WERE OPENED, AND STRIPS EXPIRATION DATE (2/19/2012), STRIPS ARE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157252 TRUBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BL3305

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR