BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 11900737 · Received May 28, 2021

    Report

    Report Number
    1000113657-2021-00344
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 4, 2021
    Report Date
    July 28, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    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 28-JUL-2021: H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-012: PRODUCT EXPIRED.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER ON A FOLLOW-UP CALL ON 05-MAY-2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED THAT SHE WAS CURRENTLY NOT HAVING ANY DIABETIC SYMPTOMS. CUSTOMER STATED THAT SHE HAD CONTACTED HER DOCTOR ON (B)(6) 2021 AND WAS ADVISED TO GO TO THE ER. CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE ER WAS 623 MG/DL. THE DIAGNOSIS WAS HYPERGLYCEMIA AND CUSTOMER WAS TREATED WITH IV FLUIDS. CUSTOMER WAS DISCHARGED THE SAME DAY; CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN DISCHARGED WAS 355 MG/DL. CUSTOMER HAD BEEN ADVISED TO FOLLOW-UP WITH HER PCP. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 14-MAY-2021 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 · 1

    CONSUMER INITIALLY REPORTED COMPLAINT FOR E-5 ERROR MESSAGE. DURING THE CALL, BACK TO BACK BLOOD TESTS WERE PERFORMED BY THE CUSTOMER FASTING AND PRODUCED E-5 ERROR AND TEST RESULT OF HI USING TRUE METRIX AIR METER. THE CUSTOMER DOES NOT KNOW HER EXPECTED GLUCOSE RANGE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING SHAKY, SHORT OF BREATH AND HAVING DRY MOUTH; CUSTOMER STATED SHE WAS GOING TO CALL HER DOCTOR. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 01/23/2021 (EXPIRED) 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 NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795713 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HAC 50CTMG/DL MW3432S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization