BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 15484871 · Received September 26, 2022

    Report

    Report Number
    1000113657-2022-00513
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    August 25, 2022
    Report Date
    October 20, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED THE INCORRECT TEST STRIPS. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. 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 A FOLLOW-UP CALL ON 13-SEP-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF(B)(6) 2022: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED THE INCORRECT TEST STRIPS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. 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.

    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 162, 136, 169, 142 AND 163 MG/DL. CUSTOMER WAS ALSO COMPARING RESULTS TO ANOTHER DEVICE (CUSTOMER DID NOT PROVIDE COMPARISON RESULTS). THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-110 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2022 SHE HAD NOT BEEN FEELING WELL (SYMPTOMS WERE NOT DISCLOSED) AND SHE HAD GONE TO THE EMERGENCY ROOM. CUSTOMER STATED SHE HAD TESTED USING THE TRUE METRIX METER AND HAD OBTAINED A BLOOD GLUCOSE TEST RESULT OF 169 MG/DL FASTING. WHEN SHE HAD ARRIVED AT THE EMERGENCY ROOM HER BLOOD GLUCOSE TEST RESULT HAD BEEN 79 MG/DL FASTING. CUSTOMER STATED THE TESTS HAD BEEN PERFORMED 15-20 MINUTES APART. THE DIAGNOSIS WAS LOW BLOOD GLUCOSE. CUSTOMER DID NOT DISCLOSE WHAT TREATMENT SHE HAD RECEIVED AND NO FURTHER INFORMATION WAS PROVIDED. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 160 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 12/23/2023 AND TEST STRIPS WERE OPENED THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 162 MG/DL, DATE: (B)(6), TIME: 06:30 AM FASTING. RESULT 2: 136 MG/DL, DATE:(B)(6), TIME: 06:42 AM FASTING. RESULT 3: 169 MG/DL, DATE: (B)(6), TIME: 06:31 AM FASTING. RESULT 4: 142 MG/DL, DATE: (B)(6), TIME: 06:36 AM FASTING. RESULT 5: 163 MG/DL, DATE: (B)(6), TIME: 06:27 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604230 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZA4811S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization