BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 18767012 · Received February 23, 2024

    Report

    Report Number
    1000113657-2024-00076
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 14, 2024
    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
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF (B)(6) 2024: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. CORRECTED SECTIONS AS OF (B)(6) 2024: H6: ADDED TYPE OF INVESTIGATION CODE 11 AND INVESTIGATION FINDINGS CODE 213 FOR RETENTION TESTING.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4) . TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED- EVALUATION IN PROCESS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 30-JAN-2024 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HER CONDITION HAD IMPROVED AND SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 215 AND 240 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS <90 MG/DL AND ONE HOUR POST MEAL EXPECTED BLOOD GLUCOSE TEST RESULT IS <140 MG/DL. THE CUSTOMER REPORTED SYMPTOMS OF HEADACHE, NAUSEA AND BLURRY VISION IN ONE EYE. CUSTOMER STATED DUE TO HER SYMPTOMS SHE HAD GONE TO THE HOSPITAL TO HAVE A BLOOD TEST DONE TO COMPARE TO THE TRUE METRIX AIR METER. CUSTOMER'S LAB BLOOD GLUCOSE TEST RESULT AT THE HOSPITAL HAD BEEN 122 MG/DL; CUSTOMER STATED SHE HAD SQUEEZED MORE BLOOD FROM THE SAME FINGER AND HAD TESTED USING THE TRUE METRIX AIR METER AND OBTAINED 240 MG/DL. CUSTOMER STATED SHE CONTACTED HER DOCTOR ABOUT HER SYMPTOMS AND THE METER TO LAB COMPARISON RESULTS. CUSTOMER STATED THE DOCTOR HAD INCREASED HER INSULIN. CUSTOMER STATED SHE TOLD THE PHYSICIAN THAT SHE FELT THE RESULTS ON THE TRUE METRIX AIR METER WERE CORRECT, SINCE SHE FELT HER BLOOD GLUCOSE LEVEL WAS HIGH BECAUSE OF WHAT SHE ATE. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. CUSTOMER IS STORING THE PRODUCT IN HER PURSE; CUSTOMER STATED THAT IT IS NOT EXPOSED TO HOT/COLD PLACES. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2025 AND TEST STRIPS WERE OPENED 1-2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS NOT CONCERNED WITH THE RESULT OF 72 MG/DL): RESULT 1: 240 MG/DL, DATE: ON (B)(6) , TIME: 4:54 PM NON-FASTING. RESULT 2: 215 MG/DL, DATE: ON (B)(6) , TIME: 4:08 PM NON-FASTING. RESULT 3: 138 MG/DL , DATE: ON (B)(6) , TIME: 4:03 PM NON-FASTING. RESULT 4: 110 MG/DL , DATE: ON (B)(6) , TIME: 3:56 PM NON-FASTING. RESULT 5: 72 MG/DL , DATE: ON (B)(6) , TIME: 3:31 PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114294 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZB5466S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O