BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 16564511 · Received March 17, 2023

    Report

    Report Number
    1000113657-2023-00154
    Event Type
    Injury
    Date Received
    March 17, 2023
    Date of Event
    February 24, 2023
    Report Date
    April 18, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    0002129200783
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 18-APR-2023: D9: DEVICE AVAILABLE FOR EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED 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-006: PASSED OPEN EXPIRATION DATE.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-006: PASSED OPEN EXPIRATION DATE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 13-MAR-2023 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 AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 263, 207, 241, 109 AND 134 MG/DL. CUSTOMER STATED THE RESULTS WERE HIGHER/LOWER THAN THE METER AT HIS DOCTOR'S OFFICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ONE WEEK AGO HIS BLOOD GLUCOSE HAD BEEN HIGH, 383 MG/DL NON-FASTING, AND HE HAD GONE TO THE ER. THE DIAGNOSIS HAD BEEN HIGH BLOOD GLUCOSE AND CUSTOMER HAD BEEN TREATED WITH INSULIN. UPON DISCHARGE, CUSTOMER'S BLOOD GLUCOSE HAD GONE DOWN TO 342 MG/DL AND HE HAD BEEN ADVISED TO FOLLOW-UP WITH HIS DOCTOR. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PRODUCT STORAGE WAS NOT DISCLOSED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2023 AND TEST STRIPS WERE OPENED MORE THAN FOUR MONTHS AGO (EXPIRED). 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 : 263 MG/DL, DATE: ON (B)(6) 2023, TIME: 07:45 AM, FASTING; RESULT 2 : 207 MG/DL, DATE: ON (B)(6) 2023, TIME: 07:37 AM, FASTING; RESULT 3 : 241 MG/DL, DATE: ON (B)(6) 2023, TIME: 07:30 AM, FASTING; RESULT 4 : 109 MG/DL, DATE: ON (B)(6) 2023, TIME: 07:54 AM, FASTING; RESULT 5 : 134 MG/DL, DATE: ON (B)(6) 2023, TIME: 09:21 AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824898 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX PBX 50CTMG/DL ZY4488S 0002129200783

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization