BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 12693756 · Received October 25, 2021

    Report

    Report Number
    1000113657-2021-00672
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 12, 2021
    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. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 08-OCT-2021 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 12-NOV-2021: H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. DEFECT FOUND ON RETURNED STRIPS: HIGH READINGS. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER ROOT CAUSE: RC-061 STORAGE OUTSIDE SPECIFICATIONS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 231, 147 AND 161MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-130MG/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 NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/22/2022 AND OPEN VIAL DATE IS (B)(6) 2021. 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 (DATE/TIME NOT SET; CUSTOMER CONFIRMED ALL WERE AM RESULTS): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592557 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 ZY4359S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown