BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 12041271 · Received June 22, 2021

    Report

    Report Number
    1000113657-2021-00402
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 30, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 30-JUL-2021: 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: (B)(6): USER HAS HIGH GLUCOSE VALUE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES: HEADACHE AND NAUSEA. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER DECLINED REPLACEMENT (TEST STRIPS/CONTROL SOLUTION WERE SENT). NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THAT THE INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING THAT PRODUCED TEST RESULT OF HI USING TRUE METRIX METER. THE CUSTOMER DOES NOT HAVE AN EXPECTED GLUCOSE RANGE; CUSTOMER STATED SHE IS A NEWLY DIAGNOSED DIABETIC. AT THE TIME OF THE CALL THE CUSTOMER REPORTED HAVING A HEADACHE AND FEELING NAUSEOUS.; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION; CUSTOMER STATED SHE HAD JUST PURCHASED THE TEST STRIPS. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 07/21/2022 AND OPEN VIAL DATE IS (B)(6) 2021. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938468 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HEB 100CTMG/DL ZX4246S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other