BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 19287014 · Received May 10, 2024

    Report

    Report Number
    1000113657-2024-00211
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 4, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 04-JUN-2024: H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE H10: ADDITIONAL INFORMATION: REPORTING CONTACT NAME CHANGED FROM: FROM (B)(6) TO (B)(6). REPORTING CONTACT EMAIL CHANGED FROM: FROM (B)(6) TO (B)(6) . NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE CUSTOMER WAS NO LONGER EXPERIENCING SYMPTOMS, UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES: SHAKY. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. 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: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 06-MAY-2024 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED THAT SHE WAS STILL FEELING SHAKY. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. CUSTOMER STATED THE REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    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 139, 163, 106, 107 AND 112 MG/DL. CUSTOMER STATED THAT THE RESULT OF 139 MG/DL NON-FASTING WAS HIGHER THAN THE LAB TEST RESULT OF 94 MG/DL NON-FASTING; CUSTOMER DID NOT CONFIRM IF THEY WERE BACK TO BACK TESTS. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS "IN THE 90'S" MG/DL. THE CUSTOMER REPORTED FEELING JITTERY AND SWEATY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. 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 07/25/2025 AND OPEN VIAL DATE WAS NOT PROVIDED. 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: 139 MG/DL DATE: 04-16 TIME: 08:29 AM NON-FASTING RESULT 2: 163 MG/DL DATE: 04-16 TIME: 07:09 AM UNKNOWN RESULT 3: 106 MG/DL DATE: 04-14 TIME: 11:55 AM UNKNOWN RESULT 4: 107 MG/DL DATE: 04-09 TIME: 05:41 AM UNKNOWN RESULT 5: 112 MG/DL DATE: 04-07 TIME: 06:18 AM UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880067 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZB5529S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other