BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4924398 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01194
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 22, 2015
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 100 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 208 MG/DL AND 222 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/16/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1: 222MG/DL (B)(6) 2015 04:54PM. 2: 205MG/DL (B)(6) 2015 04:53PM . 3: 228MG/DL (B)(6) 2015 04:44PM . 4: 231MG/DL (B)(6) 2015 04:04PM . 5: 246MG/DL (B)(6) 2015 03:57PM . ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 100 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION DUE TO METER'S RESULTS IS NOT REQUIRED AT THE TIME OF THE CALL ON (B)(6) 2015. BACK TO BACK BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2015 PRODUCED RESULTS OF 208 MG/DL AND 222 MG/DL. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPEC. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/16/2017 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED FASTING FROM METER MEMORY: 1: 222 MG/DL, (B)(6) 2015, 04:54 PM; 2: 205 MG/DL, (B)(6) 2015, 04:53 PM; 3: 228 MG/DL, (B)(6) 2015 04:44 PM; 4: 231 MG/DL, (B)(6) 2015, 04:04 PM; 5: 246 MG/DL, (B)(6) 2015, 03:57 PM. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463782 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BS4592

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR