BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 4908396 · Received July 9, 2015

    Report

    Report Number
    1052693-2015-01100
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 14, 2015
    Report Date
    January 4, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. CORRECTION OF 510(K):(B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINED OF HIGH BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 91 TO 150 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES/ COMPARING BLOOD GLUCOSE TEST RESULTS FROM TRUE2GO METER TO DOCTOR'S METER ON (B)(6) 2015; INSTRUCTED BY DOCTOR THAT METER READS TOO HIGH AFTER RECEIVING TEST RESULT OF 89 MG/DL WITH DOCTOR'S METER. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPEC. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/20/2018 AND OPEN VIAL DATE IS (B)(6) /2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:136 MG/DL (B)(6) 2015 03:00PM, 2:149 MG/DL (B)(6) 2015 03:00PM, 3:163 MG/DL (B)(6) 2015 07:30 AM, 4:143 MG/DL (B)(6) 2015 03:05PM, 5:176 MG/DL (B)(6) 2015 03:00PM.

    Description of Event or Problem · 1

    CONSUMER COMPLAINED OF HIGH BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 91 TO 150 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. COMPARING BLOOD GLUCOSE TEST RESULTS FROM TRUE2GO METER TO DOCTOR'S METER ON (B)(6) 2015; INSTRUCTED BY DOCTOR THAT METER READS TOO HIGH AFTER RECEIVING TEST RESULT OF 89 MG/DL WITH DOCTOR'S METER. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/20/2018 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1:136MG/DL (B)(6) 2015 03:00PM; 2:149MG/DL (B)(6) 2015 03:00PM; 3:163MG/DL (B)(6) 2015 07:30AM; 4:143MG/DL (B)(6) 2015 03:05PM; 5:176MG/DL (B)(6) 2015 03:00PM; ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447010 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO PS2200

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR