BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4528101 · Received February 12, 2015

    Report

    Report Number
    1052693-2015-00107
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    January 7, 2015
    Report Date
    February 12, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS SHOWED INDICATION OF BLACK CHEMISTRY CAUSED BY IMPROPER STORAGE OF TEST STRIPS IN HIGH HUMIDITY AREAS. MANUFACTURER ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (01/07/2015).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NOT VERIFIED. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. STORAGE OF TEST STRIPS NOT VERIFIED. RECALL TEST RESULTS PERFORMED (FASTING/BEFORE MEALS/AFTER MEALS) FROM METER MEMORY: (B)(6) 2015, 3:03PM - "LO"; (B)(6) 2015, 7:16PM - "LO"; (B)(6) 2015, 6:30PM - "LO"; (B)(6) 2015, 6:24PM - "LO"; (B)(6) 2015, 6:05PM - "LO"; (B)(6) 2015, 1:18PM - "LO"; (B)(6) 2015, 9:58AM - "LO"; (B)(6) 2015, 09:55AM - "LO"; (B)(6) 2015, 9:52AM - 178 MG/DL; (B)(6) 2015, 9:51AM - "LO". NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103419 TRUERESULT BLOOD GLUCSOE SYSTEM NBW NIPRO DIAGNOSTICS, INC. RUERESULT PR1993

    Patients

    Seq Age Sex Outcome Treatment
    1