BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 19696731 · Received July 8, 2024

    Report

    Report Number
    1000113657-2024-00282
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 8, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED 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. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO INQUIRED ABOUT THE VARIANCE BETWEEN RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 124, 167, 191, 209, 245 AND 264 MG/DL. CUSTOMER STATED DUE TO THE RESULTS HE TOOK INSULIN THINKING HIS BLOOD GLUCOSE WAS HIGH. CUSTOMER THEN CHECKED WITH ANOTHER METER BECAUSE HE WAS HAVING SYMPTOMS, UNDISCLOSED THE SYMPTOMS AND METER COMPARISON RESULTS. CUSTOMER STATED THE TRUE METRIX METER IS TESTING HIGH COMPARED TO HIS OTHER DEVICE. CUSTOMER STATED WHEN HE TOOK THE INSULIN HE DID NOT TAKE MORE THAN WHAT HE NEEDED BECAUSE OF THE HIGH RESULT. THE CUSTOMER DOES NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL, 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 NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/19/2025 AND OPEN VIAL DATE WAS NOT DISCLOSED. 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: 124 MG/DL DATE: 6/12/24 TIME: 11:57AM NON-FASTING RESULT 2: 167 MG/DL DATE: 6/12/24 TIME:10:08AM NON-FASTING RESULT 3: 191 MG/DL DATE :6/12/24 TIME:9:56AM NON-FASTING RESULT 4: 209 MG/DL DATE:6/12/24 TIME:8:44AM NON-FASTING RESULT 5: 245MG/DL DATE: 6/12/24 TIME: 8:41AM NON-FASTING RESULT 6: 264 MG/DL DATE: 6/12/24 TIME: 6:31AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152026 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX DDM 100CT12/CASE MG/DL ZB5410S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown