BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 24626292 · Received March 18, 2026

    Report

    Report Number
    1000113657-2026-00119
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 18, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). 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-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. 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 PHYSICAL DEFECT OF STRIPS AND ERROR MESSAGE (E-0). CUSTOMER STATED THAT HE NOTICED SOME OF THE TEST STRIPS WERE MISSING THE CONTACT END THAT GOES INTO THE METER AND SOME WERE COMPLETELY WHITE ON BOTH SIDES AND WERE PAPER THIN. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/14/2027 AND PER THE CUSTOMER THE TEST STRIPS WERE OPENED 2 WEEKS AGO. THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS, LOT ZD6179S, MANUFACTURER'S EXPIRATION DATE IS 02/28/2027 AND OPENED ON DAY OF CALL. DURING THE CALL A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING THAT PRODUCED RESULT OF 87 MG/DL USING TRUE METRIX METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686321 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 ZD6255S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown