BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 15331035 · Received August 31, 2022

    Report

    Report Number
    1000113657-2022-00465
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    July 28, 2022
    Report Date
    September 27, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    0002129200783
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 16-AUG-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 27-SEPT-2022: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS.

    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 102, 124, 129 AND 145 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70-75 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2022 HE HAD OBTAINED A RESULT OF 112 MG/DL FASTING. CUSTOMER STATED THAT DUE TO THE RESULT OBTAINED HE HAD GONE TO THE HOSPITAL; CUSTOMER STATED HE WAS NOT EXPERIENCING ANY SYMPTOMS AT THE TIME. CUSTOMER'S BLOOD GLUCOSE LAB TEST RESULT AT THE HOSPITAL WAS 51 MG/DL FASTING. CUSTOMER STATED THE TESTS HAD BEEN PERFORMED 15 MINUTES APART. CUSTOMER STATED HE WAS NOT TREATED WITH ANY MEDICATION AND THAT THE DOCTOR ADVISED HIM TO EAT. CUSTOMER WAS DISCHARGED THE SAME DAY. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS (B)(6) 2023 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 REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 102 MG/DL DATE: 08-08 TIME: 10:17 AM FASTING; RESULT 2: 102 MG/DL DATE: 08-08 TIME: 07:27 AM FASTING; RESULT 3: 124 MG/DL DATE: 08-08 TIME: 02:37 AM FASTING; RESULT 4: 129 MG/DL DATE: 08-08 TIME: 01:19 AM FASTING; RESULT 5: 145 MG/DL DATE: 08-07 TIME: 11:17 PM NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201912 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX DDM 100CT12/CASE MG/DL ZY4588S 0002129200783

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization