BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4792512 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00479
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 29, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL. REPORT #: (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: TEST STRIP ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT OF BLOOD RESULTS READING "HI". CUSTOMER STATES THAT SHE FEELS WELL, SHE STATES SHE HAS SYMPTOMS OF HYPERGLYCEMIA (THIRSTY, URINATING). CUSTOMER STATES SHE REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 94-140 MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/15/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN HER LIVING ROOM AREA AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BLOOD TEST, HI-SHE STATED THAT SHE ATE 1 HOUR AGO. REVIEWED METER MEMORY: HI (B)(6) 2015, 05:10:00 PM, FASTING: NO; 224MG/DL, (B)(6) 2015, 02:22:00 PM, FASTING: NO; 334MG/DL, (B)(6) 2015, 08:13:00 PM, FASTING: YES; 260MG/DL, (B)(6) 2015, 03:37:00 PM, FASTING: YES; 164MG/DL, (B)(6) 2015, 02:08:00 PM, FASTING: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281102 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4538

    Patients

    Seq Age Sex Outcome Treatment
    1