BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5327433 · Received December 24, 2015

    Report

    Report Number
    1052693-2015-02581
    Event Type
    Malfunction
    Date Received
    December 24, 2015
    Date of Event
    December 3, 2015
    Report Date
    December 24, 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. DEFECT FOUND - DAMAGED/DIRTY STRIP CONNECTOR. ROOT CAUSE: BENT PIN ON CODE KEY CONNECTOR. UNABLE TO DETERMINE THE CAUSE OF THE BENT PIN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 107 TO 165 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED CURRENTLY OR PRIOR TO THE CALL ON (B)(6) 2015 AS A RESULT OF THE METER'S READINGS. CUSTOMER PROVIDED THAT THEY HAVE RECENT CHANGES TO DIET, MEDICATION, OR EXERCISE. CUSTOMER ACKNOWLEDGES THAT THE BLOOD GLUCOSE RESULTS MAY BE DUE TO RECENT CHANGES TO DIET, MEDICATION, OR EXERCISE. STORAGE OF PRODUCT IS NOT CONFIRMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/18/2017 AND OPEN VIAL DATE IS 2014; TEST STRIPS EXPIRED DUE TO BEING OPEN MORE THAN 120 DAYS. THE METER MEMORY REVIEWED FOR FASTING TEST RESULTS PERFORMED (DATE / TIME NOT SET): 1:LO (B)(6) 2015 03:36PM. 2:LO (B)(6) 2015 03:35PM. 3:LO (B)(6) 2015 03:35PM. 4:143MG/DL (B)(6) 2015 09:35PM . 5:98MG/DL (B)(6) 2015 03:32PM . ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850689 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2038

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY