BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 16610487 · Received March 24, 2023

    Report

    Report Number
    1000113657-2023-00166
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    March 1, 2023
    Report Date
    April 26, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    0002129200783
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 26-APR-2023: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED TEST STRIPS: HIGH BLOOD READINGS. NO DEFECT FOUND ON RETURNED METER. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 20-MAR-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 161, 131, 127, 350 AND 261 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 91-108 MG/DL AND EXPECTED TWO HOUR POST MEAL FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 111-132 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 241 MG/DL AND 239 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/25/2024 AND TEST STRIPS WERE OPENED THREE WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 161 MG/DL, DATE: (B)(6), TIME: 09:37 PM, FASTING 2 HOUR AFTER EATING. RESULT 2: 131 MG/DL, DATE: (B)(6), TIME: 09:28 PM, FASTING 2 HOUR AFTER EATING. RESULT 3: 127 MG/DL, DATE: (B)(6), TIME: 06:07 PM, FASTING 2 HOUR AFTER EATING. RESULT 4: 350 MG/DL, DATE: (B)(6), TIME: 06:00 PM, FASTING 2 HOUR AFTER EATING. RESULT 5: 261 MG/DL, DATE: (B)(6), TIME: 06:05 AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375025 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZA4950S 0002129200783

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown