BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 20852549 · Received December 5, 2024

    Report

    Report Number
    1000113657-2024-00480
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 5, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. H1: TYPE OF REPORTABLE EVENT OF SERIOUS INJURY BEING SUBMITTED DUE TO NO DEFECT BEING FOUND ON RETURNED METER AND TEST STRIPS. 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: (B)(6): USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 22-NOV-2024 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 161, 142, 149, 159 AND 163 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 100-125 MG/DL AM FASTING AND 145-150 MG/DL PM NON-FASTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED DUE TO THE HIGH BLOOD GLUCOSE TEST RESULTS HE HAD BROUGHT THE TRUE METRIX METER TO HIS DOCTOR'S OFFICE ON (B)(6)2024. CUSTOMER STATED THAT THE TRUE METRIX METER RESULTS WERE SIGNIFICANTLY HIGHER THAN HIS DOCTOR'S METER; METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. CUSTOMER STATED THE DOCTOR ADVISED HIM TO CONTACT THE MANUFACTURER FOR A REPLACEMENT. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/31/2025. CUSTOMER STARTED USING THE PRODUCT ON (B)(6)2024. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 161 MG/DL DATE: (B)(6) 2024 TIME: 8:52 AM FASTING. RESULT 2: 142MG/DL DATE: (B)(6) 2024 TIME: 9:42 AM FASTING. RESULT 3: 149 MG/DL DATE: (B)(6) 2024 TIME: 3:23 PM NON-FASTING. RESULT 4: 159 MG/DL DATE: (B)(6) 2024 TIME: 11:39 AM FASTING. RESULT 5: 163 MG/DL DATE: (B)(6) 2024 TIME: 8:13 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049711 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, LDR TMX 30CT 24/CS MG/DL ZC5714S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other