BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 17307092 · Received July 12, 2023

    Report

    Report Number
    1000113657-2023-00376
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 19, 2023
    Report Date
    August 3, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 03-AUG-2023: D9: DEVICE AVAILABLE FOR EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER AND 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-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.

    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 (B)(6), 2023 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 BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 137, 143, 211, 156 AND 157 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-120 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT LESS THAN 2 HOURS POST EXERCISE IS 80-90 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 BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/28/2024, AND TEST STRIPS WERE OPENED ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME ONLY PROVIDED FOR FIRST RESULT): RESULT: 137 MG/DL, DATE: (B)(6), TIME: 9:05 AM FASTING, RESULT: 143 MG/DL, DATE: N/A, TIME: AM FASTING, RESULT: 211 MG/DL, DATE: N/A, TIME: PM FASTING: LESS THAN 2 HOURS POST EXERCISE, RESULT: 156 MG/DL, DATE: N/A, TIME: PM FASTING: LESS THAN 2 HOURS POST EXERCISE, RESULT: 157 MG/DL, DATE: N/A, TIME: PM FASTING: LESS THAN 2 HOURS POST EXERCISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232546 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZA5152S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown