BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4792509 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00488
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 8, 2015
    Report Date
    December 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: THE USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "HI" AND "LO" BLOOD RESULTS VIA HOME HEALTH CARE NURSE, (B)(6). EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 90 TO 140MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NOT ABLE TO BE PERFORMED DUE TO "HI" IMMEDIATELY UPON TEST STRIP INSERTION INTO METER PORT. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/19/2017 AND OPEN VIAL DATE (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: MEMORY 1: "LO", (B)(6) 2015, 08:00:00 AM, FASTING: YES; MEMORY 2: 142MG/DL, (B)(6) 2015, 03:30:00 PM, FASTING: YES; MEMORY 3: 140MG/DL, (B)(6) 2015, 03:30:00 PM, FASTING: YES; MEMORY 4: 139MG/DL, (B)(6) 2015, 03:30:00 PM, FASTING: NO; MEMORY 5: 122MG/DL, (B)(6) 2015, 03:30:00 PM, FASTING: YES. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "HI" AND "LO" BLOOD RESULTS VIA HOME HEALTH CARE NURSE, MIKE. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 90 TO 140MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NOT ABLE TO BE PERFORMED DUE TO "HI" IMMEDIATELY UPON TEST STRIP INSERTION INTO METER PORT. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/19/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: (B)(6). ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281101 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4527

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR