BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4824669 · Received June 4, 2015

    Report

    Report Number
    1052693-2015-00841
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 5, 2015
    Report Date
    December 17, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT 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 FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 157 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 270 MG/DL AND 300 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPEC. TEST STRIP LOT MFR'S EXPIRATION DATE IS 11/17/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: 1: 347MG/DL, (B)(6) 2015, 04:54PM; 2: 124MG/DL, (B)(6) 2015, 04:54PM; 3: 301MG/DL , (B)(6) 2015, 04:54PM; 4: 399MG/DL, (B)(6) 2015, 04:54PM; 5: 408MG/DL, (B)(6) 2015, 04:54PM; ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 157 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 270 MG/DL AND 300 MG/DL. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/17/2016 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
    363622 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BR4433

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR