BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4792552 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00440
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 28, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    CONSUMER COMPLAINT OF "HI" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 258 TO 300MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED DURING CALL NON-FASTING ((B)(6) 2015; 1:59PM) WITH RESULTS OF 584MG/DL AND "HI". VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MFR'S EXPIRATION DATE IS 06/24/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 369MG/DL (B)(6) 2015, 11:00AM; 170MG/DL, (B)(6) 2015, 11:00AM; 500MG/DL, (B)(6) 2015, 11:00AM; 504MG/DL, (B)(6) 2015, 11:00AM; 579MG/DL, (B)(6) 2015, 11:00AM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280519 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4582

    Patients

    Seq Age Sex Outcome Treatment
    1