BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4795161 · Received May 21, 2015

    Report

    Report Number
    1052693-2015-00773
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    April 25, 2015
    Report Date
    January 4, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS VIA HUSBAND. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 100 TO 120 MG/DL. COMPARING BLOOD GLUCOSE RESULTS FROM HIS TRUETRACK METER (B)(4) TO WIFE'S TRUETRACK METER (B)(4) AND OBSERVED 60 TO 80 MG/DL DIFFERENCE. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST DECLINED. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 312 MG/DL, (B)(6) 2015, 09:09 AM; 161 MG/DL, (B)(6) 2015, 08:00 AM; 131 MG/DL, (B)(6) 2015, 09:30 AM; 130 MG/DL, (B)(6) 2015, 07:00 AM; 128 MG/DL, (B)(6) 2015, 09:04 AM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS VIA HUSBAND. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 100 TO 120MG/DL. COMPARING BLOOD GLUCOSE RESULTS FROM HIS TRUETRACK METER (B)(4) TO WIFE'S TRUETRACK METER (B)(4) AND OBSERVED 60 TO 80MG/DL DIFFERENCE. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST DECLINED. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 312MG/DL (B)(6) 2015 09:09AM; 161MG/DL (B)(6) 2015 08:00AM; 131MG/DL (B)(6) 2015 09:30AM; 130MG/DL (B)(6) 2015 07:00AM; 128MG/DL (B)(6) 2015 09:04AM; ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333782 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4516

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR