BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 24742971 · Received March 31, 2026

    Report

    Report Number
    1000113657-2026-00141
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 31, 2026
    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 Occupation
    OTHER

    Narratives

    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 E-5 PRODUCT CORRECTION NOTICE LETTER. 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-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGE (E-2). CUSTOMER WAS ALSO CALLING REGARDING THE E-5 CORRECTION LETTER; CUSTOMER STATED SHE DID NOT GET E-5 ON HER METER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 125, 133, 125, 108 AND 110 MG/DL. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT IS 90 MG/DL FASTING AM. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER STATED SHE CONTACTED HER DR ABOUT A WEEK AGO (SHE DID NOT RECALL THE DATE) REGARDING HER CONCERNS WITH THE HIGH BLOOD RESULTS AND THE LETTER SHE RECEIVED ABOUT THE E-5 PRODUCT CORRECTION NOTICE. PER CUSTOMER THE DR WROTE A PRESCRIPTION FOR A DIFFERENT BRAND METER. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CUSTOMER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/15/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE WAS 3 WEEKS AGO. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 125 MG/DL; DATE: 3/3/2026; TIME: 6:33AM FASTING AM. RESULT 2: 133 MG/DL; DATE: 3/2/2026; TIME: 8:13AM FASTING AM. RESULT 3: 125 MG/DL; DATE: 3/1/2026; TIME: 8:47AM FASTING AM. RESULT 4: 108 MG/DL; DATE: 2/28/2026; TIME: 6:03PM FASTING PM. RESULT 5: 110 MG/DL; DATE: 2/27/2026; TIME: 7:02AM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801337 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL ZD6296S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other