BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4762654 · Received May 7, 2015

    Report

    Report Number
    1052693-2015-00692
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    April 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAD LOW GLUCOSE RESULTS TO TEST STRIP ISSUE INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 99 TO 109 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED DURING CALL FASTING ((B)(6) 2015; 1:20 PM) WITH RESULTS OF 108 MG/DL AND 143 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: "LO" (B)(6) 2015 09:00 AM FASTING: YES; 109 MG/DL (B)(6) 2015 09:00 AM FASTING: YES; 110 MG/DL (B)(6) 2015 09:00 AM FASTING: YES; 110 MG/DL (B)(6) 2015 09:00 AM FASTING: YES; 113 MG/DL (B)(6) 2015 09:00 AM FASTING: NO. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 99 TO 109MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. BACK TO BACK BLOOD TEST PERFORMED DURING CALL FASTING ((B)(6) 2015; 1:20PM) WITH RESULTS OF 108MG/DL AND 143MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: "LO" (B)(6) 2015 09:00AM FASTING:YES. 109MG/DL (B)(6) 2015 09:00AM FASTING:YES. 110MG/DL (B)(6) 2015 09:00AM FASTING:YES. 110MG/DL (B)(6) 2015 09:00AM FASTING:YES. 113MG/DL (B)(6) 2015 09:00AM FASTING:NO. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299884 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2123

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR