BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 4792508 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00487
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 29, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: USER HAD AN INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FORM 100 TO 130 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION TO MAANGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED DURING CALL FASTING ((B)(6) 2015; 2:58PM) WITH RESULTS OF 179MG/DL AND 223MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/22/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: 173MG/DL, (B)(6) 2015, 12:00:00 AM, FASTING: YES; 223MG/DL, (B)(6) 2015, 12:00:00 AM, FASTING: YES; 173MG/DL, (B)(6) 2015, 12:00:00 PM, FASTING: NO; 170MG/DL, (B)(6) 2015, 03:02:00 PM, FASTING: YES; 172MG/DL, (B)(6) 2015, 03:02:00 PM, FASTING: NO. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280435 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO PR2097

    Patients

    Seq Age Sex Outcome Treatment
    1