BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 15580338 · Received October 11, 2022

    Report

    Report Number
    1000113657-2022-00533
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 14, 2022
    Report Date
    November 4, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 28-SEP-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 04-NOV-2022: 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 TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 282, 242, 175, 173 AND 143 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-115 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 145-160 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 TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/24/2024 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY, LOT NUMBER ZA4789S, MANUFACTURER¿S EXPIRATION DATE IS 11/30/2023. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 247 MG/DL USING TRUE METRIX METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 282 MG/DL DATE: (B)(6) 2022 TIME: 11:19PM FASTING (TAKEN TODAY FASTING AM), RESULT 2: 242 MG/DL DATE: (B)(6) 2022 TIME: 9:03AM FASTING PM , RESULT 3: 175 MG/DL DATE: (B)(6) 2022 TIME: 7:59AM FASTING PM, RESULT 4: 173 MG/DL DATE: (B)(6) 2022 TIME: 8:53PM FASTING PM, RESULT 5: 143 MG/DL DATE: (B)(6) 2022 TIME: 9:53PM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306934 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL MA4534S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown