BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4730235 · Received April 23, 2015

    Report

    Report Number
    1052693-2015-00588
    Event Type
    Malfunction
    Date Received
    April 23, 2015
    Date of Event
    March 30, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NON-FASTING RANGE FROM 125 TO 160 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION AND INSULIN TO MANAGE DIABETES. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/13/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: (B)(6). BASED ON THE "LO" RESULTS RECALLED IN THE METER MEMORY AND OBTAINED BY THE CUSTOMER, THE COMPLAINT IS REPORTABLE. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS NON-FASTING RANGE FROM 125 TO 160 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. CURRENTLY TAKING MEDICATION AND INSULIN TO MANAGE DIABETES. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MFR'S EXPIRATION DATE IS 07/13/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: MEMORY 1:"LO" (B)(6) 2015 04:50PM FASTING: NO; MEMORY 2:140MG/DL (B)(6) 2015 04:50PM FASTING: YES; MEMORY 3:210MG/DL (B)(6) 2015 04:50PM FASTING: YES; MEMORY 4:181MG/DL (B)(6) 2015 04:50PM FASTING: NO; MEMORY 5:126MG/DL (B)(6) 2015 04:50PM FASTING: YES. BASED ON THE "LO" RESULTS RECALLED IN THE METER MEMORY AND OBTAINED BY THE CUSTOMER, THE COMPLAINT IS REPORTABLE. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269793 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2031

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR