BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5098950 · Received September 23, 2015

    Report

    Report Number
    1052693-2015-01773
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 31, 2015
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: THE USER HAD AN INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THEY FEEL WELL AND THAT NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 166MG/DL. VERIFIED THE STRIPS EXPIRE 07/21/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST 84MG/DL AND 77MG/DL FASTING. REVIEWED METER MEMORY: 1:95MG/DL (B)(6) 2015 04:18:00 PM FASTING:YES. 2:100MG/DL (B)(6) 2015 04:14:00 PM FASTING:YES. 3:71MG/DL (B)(6) 2015 08:50:00 AM FASTING:YES. 4:72MG/DL (B)(6) 2015 05:44:00 PM FASTING:YES. 5:120MG/DL (B)(6) 2015 04:08:00 PM FASTING:YES. CUSTOMERS CONCERN:71 MG/DL AND 72 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THEY FEEL WELL AND THAT NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 166MG/DL. VERIFIED THE STRIPS EXPIRE 07/21/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST 84MG/DL AND 77MG/DL FASTING. REVIEWED METER MEMORY: 95MG/DL, (B)(6) 2015, 04:18:00 PM, FASTING:YES. 100MG/DL, (B)(6) 2015, 04:14:00 PM, FASTING:YES. 71MG/DL, (B)(6) 2015, 08:50:00 AM, FASTING:YES. 72MG/DL, (B)(6) 2015, 05:44:00 PM, FASTING:YES. 120MG/DL, (B)(6) 2015, 04:08:00 PM ,FASTING:YES. CUSTOMERS CONCERN:71 MG/DL AND 72 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628748 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2416

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR