BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5247650 · Received November 24, 2015

    Report

    Report Number
    1052693-2015-02309
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 24, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: USER'S TEST STRIP HAD POOR FILL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 160 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 WAS IN HOSPITAL FOR UNRELATED ILLNESS FROM (B)(6) 2015. BACK TO BACK BLOOD TEST PERFORMED BY CUSTOMER NON-FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 105 MG/DL AND 105 MG/DL. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/14/2017 AND OPEN VIAL DATE IS WEEK OF (B)(6) 2015. THE METER MEMORY RECALLED FOR FASTING TEST RESULTS PERFORMED (88 MG/DL IS NOT CUSTOMER'S BLOOD GLUCOSE TEST RESULT - WIFE'S): 1:98MG/DL 10/29/2015 09:49AM, 2:90MG/DL 10/29/2015 09:47AM , 3:97MG/DL 10/29/2015 09:45AM , 4:88MG/DL 10/29/2015 09:43AM , 5:278MG/DL 10/29/2015 09:53PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775653 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2033

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY