BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 11723351 · Received April 26, 2021

    Report

    Report Number
    1000113657-2021-00279
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    February 1, 2021
    Report Date
    June 8, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007829
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 08-JUN-2021: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS NOT RETURNED FOR EVALUATION - CUSTOMER RETURNED INCORRECT METER. 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-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.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). EXPECTED PRODUCT NOT RECEIVED. CUSTOMER RETURNED INCORRECT METER. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 19-APR- 2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED IS COMFORTABLE WITH THE RESULTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 150, 329, 337 AND 296MG/DL AND FROM METER TO METER COMPARISON OF 144MG/DL USING TRUE METRIX AIR METER AND 82MG/DL USING ANOTHER DEVICE. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-107MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2021 HE HAD OBTAINED THE RESULT OF 329MG/DL AND HAD SYMPTOMS OF HEADACHE AND SWEATING. CUSTOMER STATED THAT HE HAD GONE TO THE HOSPITAL. CUSTOMER'S BLOOD GLUCOSE TEST RESULT AT THE HOSPITAL FOUR HOURS LATER WAS 133MG/DL. CUSTOMER WAS NOT TREATED OR ADMITTED AND WAS DISCHARGED THE SAME DAY. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/31/2021 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS, SAME LOT NUMBER, THAT HAD BEEN STORED AND HANDLED CORRECTLY. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 90MG/DL USING TRUE METRIX AIR METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624737 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX PBX 25CT24/CASE MG/DL MX4317S 00021292007829

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization