BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 16183556 · Received January 17, 2023

    Report

    Report Number
    1000113657-2023-00033
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 21, 2022
    Report Date
    February 13, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 04 JAN 2023 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 13-FEB-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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGE (E-0). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 281, 327, 254, 186 AND 183 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 140 MG/DL AND EXPECTED PM NON-FASTING BLOOD GLUCOSE TEST RESULT IS 250 MG/DL. 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 263 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2023 AND OPEN VIAL DATE IS 12/19/2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 281 MG/DL, DATE: (B)(6), TIME: 07:09 PM, FASTING- BLOOD TEST WAS TAKEN MORNING; RESULT 2: 327 MG/DL, DATE: (B)(6), TIME: 06:04 PM, FASTING- BLOOD TEST WAS TAKEN MORNING; RESULT 3: 254 MG/DL, DATE: (B)(6), TIME: 06:03 PM, FASTING- BLOOD TEST WAS TAKEN MORNING; RESULT 4: 186 MG/DL, DATE: (B)(6), TIME: 01:40 PM, FASTING- BLOOD TEST WAS TAKEN MORNING; RESULT 5: 183 MG/DL, DATE: 04/16 TIME: 09:30 AM, FASTING- BLOOD TEST WAS TAKEN MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470342 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS50CT 360/CS MG/DL ZA4760S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown