BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4924416 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01208
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 23, 2015
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET EVALUATED. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. EXPECTED AFTER MEAL BLOOD GLUCOSE TEST RESULT RANGE IS 130 TO 160 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 97 MG/DL AND 94 MG/DL). VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (TIME NOT SET): 1:104MG/DL (B)(6) 2015 05:03PM. 2:77MG/DL (B)(6) 2015 04:59PM . 3:87MG/DL (B)(6) 2015 04:58PM. 4:80MG/DL (B)(6) 2015 04:57PM . 5:114MG/DL (B)(6) 2015 06:13PM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. EXPECTED AFTER MEAL BLOOD GLUCOSE TEST RESULT RANGE IS 130 TO 160 MG/DL. CUSTOMER FEELS WELL BUT OBSERVED SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6)2015 PRODUCED RESULTS OF 97 MG/DL AND 94 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIPS LOT MFR'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY (TIME NOT SET): 104MG/DL (B)(6) 2015 05:03PM; 77MG/DL (B)(6) 2015 04:59PM; 87MG/DL (B)(6) 2015 04:58PM; 80MG/DL (B)(6) 2015 04:57PM; 114MG/DL (B)(6) 2015 06:13PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463785 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4676

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR