BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 20980155 · Received December 19, 2024

    Report

    Report Number
    1000113657-2024-00503
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 2, 2024
    Report Date
    January 23, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 23-JAN-2025: D9: DEVICE AVAILABLE FOR EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS AND SYMPTOMS RELATED TO DIABETES (NAUSEA). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 09-DEC-2024 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 192, 325, 313, 263 AND 254 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 160 MG/DL AND 2-HOUR POST MEAL EXPECTED BLOOD GLUCOSE TEST RESULT IS BELOW 180 MG/DL. THE CUSTOMER FEELS WELL AT THE TIME OF THE CALL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT WHEN HE WAS GETTING THE ERRATIC RESULTS EARLIER TODAY, HE WAS FEELING NAUSEATED, AND HE WENT TO HIS DOCTOR'S OFFICE. CUSTOMER STATED THAT WHEN HE WENT, THE DOCTOR DID NOT TAKE A BLOOD GLUCOSE TEST BUT THAT THEY TOOK AN A1C AND ADVISED THAT IT WAS "NORMAL". DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 170 MG/DL AND 171 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DEN. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/31/2026 AND TEST STRIPS WERE OPENED 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 192 MG/DL DATE: 12/2/2024 TIME: 6:32 PM FASTING RESULT 2: 325 MG/DL DATE: 12/2/2024 TIME: 3:58 PM NON-FASTING RESULT 3: 313 MG/DL DATE: 12/2/2024 TIME: 3:54 PM NON-FASTING RESULT 4: 263 MG/DL DATE: 12/2/2024 TIME: 3:45 PM NON-FASTING RESULT 5: 254 MG/DL DATE: 12/2/2024 TIME: 3:37 PM NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098385 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZC5754S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other