BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 15138185 · Received August 1, 2022

    Report

    Report Number
    1000113657-2022-00422
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 29, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE RETURNED PRODUCT EVALUATION IN-PROCESS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 20-JUL-2022 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 29-AUG-2022: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: CUSTOMER RETURNED REPLACEMENT METER. TEST STRIPS RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED ON RETURNED STRIPS. PRODUCT EVALUATION HAS BEEN COMPLETED. ADDED MOST LIKELY UNDERLYING ROOT CAUSE. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 152, 174, 142, 120, 169 AND 138 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-105 MG/DL AND EXPECTED 2 HOURS POST MEAL BLOOD GLUCOSE TEST RESULT IS 135 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. THE CUSTOMER WAS NOT USING PROPER TESTING TECHNIQUE. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 126 MG/DL AND 149 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2023 AND TEST STRIPS WERE OPENED A FEW DAYS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 152 MG/DL DATE: (B)(6) 2022 TIME: 3:00 AM FASTING RESULT 2: 174 MG/DL DATE: (B)(6) 2022 TIME: 3:00 AM FASTING RESULT 3: 142 MG/DL DATE: (B)(6) 2022 TIME: 9:30 AM FASTING RESULT 4: 120 MG/DL DATE: (B)(6) 2022 TIME: 9:30 AM FASTING RESULT 5: 169 MG/DL DATE: (B)(6) 2022 TIME: 7:00 PM 2 HRS. AFTER MEAL RESULT 6: 138 MG/DL DATE: (B)(6) 2022 TIME: 7:00 PM 2 HRS. AFTER MEAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332206 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZA4768S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown