BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4702012 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00552
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 23, 2015
    Report Date
    April 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION. USER HAD INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NOT FASTING IS ABOUT 155 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED DURING CALL NOT FASTING ((B)(6) 2015; 4:21 PM) WITH RESULTS OF 192 MG/DL AND 212 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2017 AND OPEN VIAL DATE IS ONE MONTH. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: MEMORY 1:289MG/DL (B)(6) 2015 04:24PM FASTING: YES. MEMORY 2:325MG/DL (B)(6) 2015 04:24PM FASTING: YES. MEMORY 3:269MG/DL (B)(6) 2015 04:24PM FASTING: YES. MEMORY 4:275MG/DL (B)(6) 2015 04:24PM FASTING: NO. MEMORY 5:280MG/DL (B)(6) 2015 04:24PM FASTING: NO. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252564 TRUERESULT BLODO GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. SIDEKICK SR4549

    Patients

    Seq Age Sex Outcome Treatment
    1