BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 16751799 · Received April 17, 2023

    Report

    Report Number
    1000113657-2023-00214
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 16, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 16-MAY-2023: 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. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). 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-061: STORAGE OUTSIDE SPECIFICATIONS. NOTE: 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 142, 157, 160, 166 AND 161 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-130 MG/DL. THE CUSTOMER STATED THE RESULTS OBTAINED WERE 20-40 POINTS HIGHER THAN HIS OLD METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER STATED THAT HE WENT TO THE LAB TODAY AS A ROUTINE CHECKUP; HE HAD OBTAINED A RESULT OF 160 MG/DL USING THE TRUE METRIX AIR METER AND AN HOUR LATER AT THE LAB HIS RESULT HAD BEEN 125 MG/DL. 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 OFFICE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/31/2023 AND OPEN VIAL DATE IS 02/2023. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 142 MG/DL DATE: 3/1 TIME: 5:28 AM FASTING, RESULT 2: 157 MG/DL DATE: 2/28 TIME: 6:30 AM FASTING, RESULT 3: 160 MG/DL DATE: 2/27 TIME: 5:30 AM FASTING, RESULT 4: 166 MG/DL DATE: 2/24 TIME: 5:30 AM FASTING, RESULT 5: 161 MG/DL DATE: 2/23 TIME: 6:30 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309217 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS50CT 360/CS MG/DL ZA4832S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown