BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 18768477 · Received February 23, 2024

    Report

    Report Number
    1000113657-2024-00077
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 12, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED - PRODUCT EVALUATION IN-PROCESS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 14-FEB-2024 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN, CUSTOMER STATED THEY ARE COMFORTABLE WITH THE READINGS FROM THE REPLACEMENT PRODUCTS.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 12-MAR-2024: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED TEST STRIPS: HIGH RESULTS. NO DEFECT FOUND ON RETURNED METER. ROOT CAUSE: RC-072: VIAL LEFT OPEN FOR AN EXTENDED PERIOD OF TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 315, 220, 168, 192 AND 210 MG/DL. WIFE STATED THAT CUSTOMER WENT TO HIS REGULAR CHECK UP ON (B)(6) 2024 AND BEFORE THE APPOINTMENT HE TESTED WITH THE TRUE METRIX AIR AND RESULT WAS 210 MG/DL FASTING AM; THE LAB TEST WAS 164 MG/DL AM FASTING (UNKNOWN HOW LONG APART BETWEEN THE TESTS). CUSTOMER HAD LET THE DOCTOR KNOW ABOUT THE DIFFERENCE AND THE DOCTOR REFERRED HIM TO THE MANUFACTURER. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULTS ARE 120 MG/DL AM FASTING AND 157 MG/DL PM FASTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/31/2024 AND OPEN VIAL DATE IS (B)(6) 2023. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 315 MG/DL DATE: 1/23 TIME: 11:19PM FASTING RESULT 2: 220 MG/DL DATE: 1/23 TIME: 11:17PM FASTING RESULT 3: 168 MG/DL DATE: 1/22 TIME: 7:35PM FASTING RESULT 4: 192 MG/DL DATE: 1/21 TIME: 11:35PM FASTING RESULT 5: 210 MG/DL DATE: 1/21 TIME: 11:33PM FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236874 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZB5286S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown