BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4792503 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00660
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 4, 2015
    Report Date
    December 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NON-FASTING RANGE FROM 80 TO 142MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. COMPARING BLOOD GLUCOSE TEST RESULTS TO SOLISV2 METER AND CLAIMS RESULTS ARE 40MG/DL HIGHER. BLOOD TEST PERFORMED USING BOTH METERS AND TEST RESULT WAS 120MG/DL WITH SOLISV2 METER AND 160MG/DL WITH TRUERESULT METER. BACK TO BACK BLOOD TEST PERFORMED DURING CALL NON-FASTING ((B)(6) 2015; 12:05PM) WITH RESULTS OF 119MG/DL 119MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MFR'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: 45MG/DL, (B)(6) 2015, 11:18AM; 160MG/DL, (B)(6) 2015, 11:04AM. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NON-FASTING RANGES FROM 80 TO 142MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. COMPARING BLOOD GLUCOSE TEST RESULTS TO SOLISV2 METER AND CLAIMS RESULTS ARE 40MG/DL HIGHER. BLOOD TEST PERFORMED USING BOTH METERS AND TEST RESULT WAS 120MG/DL WITH SOLISV2 METER AND 160MG/DL WITH TRUERESULT METER. BACK TO BACK BLOOD TEST PERFORMED DURING CALL NON-FASTING ((B)(6) 2015; 12:05PM) WITH RESULTS OF 119MG/DL AND 119MG/DL. VERIFIED STORAGE OF TEST STRIPS 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 NON-FASTING FROM METER MEMORY: (B)(6). ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281099 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2158

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR