BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5100577 · Received September 24, 2015

    Report

    Report Number
    1052693-2015-01776
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 1, 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
    WI
    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'S TEST STRIP WAS STORED IN POOR STORAGE CONDITIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES SHE FEELS WELL AND STATES SHE DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 134-143MG/DL. VERIFIED THE STRIPS EXPIRE 12/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST 134MG/DL AND 143MG/DL FASTING. REVIEWED METER MEMORY: 1: 177MG/DL (B)(6) 2014 11:40:00 AM FASTING:NO. 2: 170MG/DL (B)(6) 2014 11:30:00 AM FASTING:NO. 3: 163MG/DL (B)(6) 2014 11:26:00 AM FASTING:NO. 4: LO (B)(6) 2014 11:25:00 AM FASTING:NO. 5: 119MG/DL (B)(6) 2014 07:59:00 AM FASTING:YES. CUSTOMERS CONCERN:LO. DATE AND TIME OF THE METER WAS NOT SET WITH CORRECT DATES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LO RESULTS. CUSTOMER STATES SHE FEELS WELL AND STATES SHE DOES NOT REQUIRE MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 134-143MG/DL. VERIFIED THE STRIPS EXPIRE 12/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WERE FIRST OPENED 09/01/2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST 134MG/DL AND 143MG/DL FASTING. REVIEWED METER MEMORY (B)(6). CUSTOMERS CONCERN:LO. DATE AND TIME OF THE METER WAS NOT SET WITH CORRECT DATES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632349 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2188

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR