BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 14504801 · Received May 26, 2022

    Report

    Report Number
    1000113657-2022-00305
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 25, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. METER AND TEST STRIPS WERE RETURNED. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER AND STRIP. PRODUCT EVALUATION HAS BEEN COMPLETED. ADDED MOST LIKELY UNDERLYING ROOT CAUSE. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    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 132, 125, 214 AND 241MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 100MG/DL AM FASTING AND 175MG/DL PM FASTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED DUE TO THE HIGH RESULTS SHE HAD GONE TO HER DOCTOR'S OFFICE THAT DAY; CUSTOMER COULDN'T SPEAK TO HER DOCTOR BUT SHE SPOKE TO THE NURSE ABOUT THE HIGH BLOOD RESULTS. THE NURSE PERFORMED THE BLOOD TEST WITH THEIR METER AND THE RESULT WAS 193MG/DL PM FASTING; LESS THAN A MINUTE LATER THEY PERFORMED THE TEST WITH THE TRUE METRIX METER AND RESULT WAS 168MG/DL PM FASTING. CUSTOMER STATED THE TRUE METRIX RESULT WAS LOWER THAN THE DOCTOR'S DEVICE. NURSE RECOMMENDED CUSTOMER CONTACT MANUFACTURER CHECK IF METER IS WORKING PROPERLY. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2023 AND TEST STRIPS WERE OPENED ONE MONTH PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 168MG/DL DATE: 04/29 TIME: 1:11PM FASTING. RESULT 2: 89MG/DL DATE: 04/29 TIME: 4:34 AM FASTING. RESULT 3: 178MG/DL DATE: 04/28 TIME: 3:47PM FASTING. RESULT 4: 132MG/DL DATE: 04/28 TIME: 6:28AM FASTING. RESULT 5: 125MG/DL DATE: 04/28 TIME: 6:23AM FASTING. RESULT 6: 214MG/DL DATE: 04/26 TIME: 4:30PM FASTING. RESULT 7: 241MG/DL DATE: 04/26 TIME: 8:25AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331533 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, WGN TMX 30CT 24/CASE MG/DL ZY4562S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other