BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE RESULT

    MDR report key: 4924475 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01169
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 20, 2015
    Report Date
    July 16, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 111MG/DL AND 123MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPEC SINCE THEY ARE KEPT IN BEDROOM. TEST STRIP LOT MFR'S EXPIRATION DATE IS 03/31/2018 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (DATE / TIME NOT SET): 170MG/DL (B)(6) 2015 07:18AM FASTING YES; 182MG/DL (B)(6) 2015 07:10AM FASTING YES; 182MG/DL (B)(6) 2015 07:10AM FASTING YES; 190MG/DL (B)(6) 2015 07:05AM FASTING YES; 167MG/DL (B)(6) 2015 07:03AM FASTING YES. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463765 TRUE RESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUE RESULT PS2271

    Patients

    Seq Age Sex Outcome Treatment
    1