BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5268082 · Received December 4, 2015

    Report

    Report Number
    1052693-2015-02369
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Date of Event
    November 8, 2015
    Report Date
    December 7, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED AND EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: USER'S TEST STRIP HAD POOR FILL.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED AND EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: USER'S TEST STRIP HAD POOR FILL. TYPE OF REPORTABLE EVENT, INADVERTENTLY "DEATH" WAS SELECTED, THE CORRECT OPTION FOR THIS COMPLAINT IS "MALFUNCTION".

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 130-160MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 3/17/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN PROPERLY STORED AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BLOOD TEST AND OBTAINED 64MG/DL. REVIEWED METER MEMORY. 1:65MG/DL (B)(6) 2015 07:28:00 PM FASTING:NO. 2:72MG/DL (B)(6) 2015 07:28:00 PM FASTING:NO. 3:61MG/DL (B)(6) 2015 07:27:00 PM FASTING:NO. 4:60MG/DL (B)(6) 2015 07:25:00 PM FASTING:NO. CUSTOMER IS CONCERN WITH ALL THESE RESULTS BECAUSE THEY WERE TAKEN ON 3 DIFFERENT PERSON AND ALL THE RESULTS ARE LOW. CUSTOMER CALLING STATES THAT HE JUST PURCHASE THE METER AN HOUR AGO AND TESTED 3 DIFFERENT PEOPLE AND DOES NOT TRUST THE METER RESULTS. CHECK MEMORY AND THE TIME ARE NOT SET CORRECTLY. ONLY TWO RESULTS IN THE METER MEMORY BELONG TO THE CUSTOMER RESULTS TAKEN ON (B)(6) 2015 65MG/DL AND 60MG/DL.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 130-160MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 3/17/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN PROPERLY STORED AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BLOOD TEST AND OBTAINED 64MG/DL. 65MG/DL, (B)(6) 2015 07:28:00 PM, FASTING:NO. 72MG/DL, (B)(6) 2015 07:28:00 PM, FASTING:NO. 61MG/DL, (B)(6) 2015 07:27:00 PM, FASTING:NO.. 4:60MG/DL, (B)(6) 2015 07:25:00 PM, FASTING:NO. CUSTOMER IS CONCERN WITH ALL THESE RESULTS BECAUSE THEY WERE TAKEN ON 3 DIFFERENT PERSON AND ALL THE RESULTS ARE LOW. CUSTOMER CALLING STATES THAT HE JUST PURCHASE THE METER AN HOUR AGO AND TESTED 3 DIFFERENT PEOPLE AND DOES NOT TRUST THE METER RESULTS. CHECK MEMORY AND THE TIME ARE NOT SET CORRECTLY. ONLY TWO RESULTS IN THE METER MEMORY BELONG TO THE CUSTOMER RESULTS TAKEN ON (B)(6) 2015 65MG/DL AND 60MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798273 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2246

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR