BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 16888643 · Received May 8, 2023

    Report

    Report Number
    1000113657-2023-00258
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 13, 2023
    Report Date
    June 1, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 01-JUN-2023: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 158, 102, 164, 165 AND 148 MG/DL. CUSTOMER ALSO STATED THE TRUE METRIX METER RESULTS WERE ABOUT 40 POINTS HIGHER COMPARED TO ANOTHER METER THAT HE USES. CUSTOMER STATED THAT THE TRUE METRIX METER WAS GIVING A READING OF 80 MG/DL, HE TESTED WITH THE OTHER METER, AND IT WAS SHOWING 40 MG/DL. CUSTOMER WAS HAVING SYMPTOMS OF BLURRY VISION, SO HE KNOWS HIS BLOOD SUGAR WAS LOW, IN THE 40S. CUSTOMER DID NOT HAVE TO SEEK ANY MEDICAL INTERVENTION HE JUST DRANK SOME SODA TO BRING IT BACK UP. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 110 MG/DL AND EXPECTED BLOOD GLUCOSE TEST RESULT PM FASTING IS 110 MG/DL (4HR AFTER EATING). 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/26/2024 AND OPEN VIAL DATE IS ABOUT ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 158 MG/DL DATE: (B)(6) 2023, TIME: 4:14 PM FASTING PM. RESULT 2: 102 MG/DL DATE: (B)(6) 20203, TIME: 12:43 PM UNSURE. RESULT 3: 164 MG/DL DATE: (B)(6) 2023, TIME: 11:47 PM UNSURE. RESULT 4: 165 MG/DL DATE: (B)(6) 2023, TIME: 11:45 PM UNSURE. RESULT 5: 148 MG/DL DATE: (B)(6) 2023, TIME: 12:38 PM UNSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902391 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX AID 100CT12/CASE MG/DL ZA4859S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown