BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4874107 · Received June 25, 2015

    Report

    Report Number
    1052693-2015-00972
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 29, 2015
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER'S TEST STRIP HAD POOR FILL. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS NOT KNOWN. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BLOOD TEST PERFORMED NON-FASTING PRODUCED RESULT OF 23 MG/DL. PATIENT'S GRANDDAUGHTER PERFORMED BLOOD TEST AND PRODUCED RESULT OF 24 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: 1:22MG/DL (B)(6) 2015 04:44PM FASTING:NO. 2:24MG/DL (B)(6) 2015 04:43PM FASTING:NO. 3:23MG/DL (B)(6) 2015 04:37PM FASTING:NO. 4:22MG/DL (B)(6) 2015 04:34PM FASTING:NO. 5:182MG/DL (B)(6) 2015 11:32AM FASTING:YES. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS NOT KNOWN. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BLOOD TEST PERFORMED NON-FASTING PRODUCED RESULT OF 23 MG/DL. PT'S GRANDDAUGHTER PERFORMED BLOOD TEST AND PRODUCED RESULT OF 24 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPEC. TEST STRIP LOT MFR'S EXPIRATION DATE IS 07/31/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FROM METER MEMORY: 1:22MG/DL, (B)(6) 2015, 04:44PM, FASTING: NO; 2:24MG/DL, (B)(6) 2015, 04:43PM, FASTING: NO; 3:23MG/DL, (B)(6) 2015, 04:37PM, FASTING: NO; 4:22MG/DL, (B)(6) 2015, 04:34PM, FASTING: NO; 5:182MG/DL, (B)(6) 2015, 11:32AM, FASTING: YES; ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411842 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2056

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR