BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4808495 · Received May 28, 2015

    Report

    Report Number
    1052693-2015-00825
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 4, 2015
    Report Date
    December 18, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION TEST STRIPS. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF RECEIVING AN E3 ERROR MESSAGE. UPON TROUBLESHOOTING HIGH CONTROL TEST RESULTS WERE OBTAINED. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER WAS NOT SURE WHAT HIS EXPECTED RESULT SHOULD BE. VERIFIED THE STRIPS EXPIRE 02/28/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. REVIEWED METER MEMORY: 148 MG/DL, (B)(6) 2015, 09:30 AM, FASTING: YES; 132 MG/DL, (B)(6) 2015, 09:30 AM, FASTING: YES; 124 MG/DL, (B)(6) 2015, 09:30 AM, FASTING: YES; 121 MG/DL, (B)(6) 2015, 09:30 AM, FASTING: YES; 142 MG/DL, (B)(6) 2015, 09:30 AM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF RECEIVING AN E3 ERROR MESSAGE. UPON TROUBLESHOOTING HIGH CONTROL TEST RESULTS WERE OBTAINED. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER WAS NOT SURE WHAT HIS EXPECTED RESULT SHOULD BE. VERIFIED THE STRIPS EXPIRE 02/28/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. REVIEWED METER MEMORY: 1:148MG/DL (B)(6) 2015 09:30:00 AM FASTING:YES. 2:132MG/DL (B)(6) 2015 09:30:00 AM FASTING:YES. 3:124MG/DL (B)(6) 2015 09:30:00 AM FASTING:YES. 4:121MG/DL (B)(6) 2015 09:30:00 AM FASTING:YES. 5:142MG/DL (B)(6) 2015 09:30:00 AM FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344770 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2231

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR