BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11703267 · Received April 21, 2021

    Report

    Report Number
    1000113657-2021-00272
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 24, 2021
    Report Date
    May 26, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 26-MAY-2021: D8: WAS THIS DEVICE SERVICED BY A THIRD PARTY. D9: DEVICE AVAILABLE FOR EVALUATION. H2 DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS H10: METER AND STRIPS WERE RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED.- NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE MLC-012 USE/STORAGE-USE OF EXP PROD.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4) - SAME METER, DIFFERENT TEST STRIPS. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER ON A FOLLOW-UP CALL ON 31-MAR-2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. CUSTOMER REPORTED THAT SHE HAD GONE TO THE HOSPITAL ON (B)(6) 2021 DUE TO THE LOW BLOOD GLUCOSE TEST RESULT. CUSTOMER STATED SHE WAS NOT HAVING SYMPTOMS OF THE TIME. CUSTOMER STATED A METER TO METER COMPARISON WAS PERFORMED AND RESULTS OBTAINED OF 64MG/DL USING TRUE METRIX METER AND 119MG/DL USING HOSPITAL'S DEVICE (FASTING/NON-FASTING NOT DISCLOSED). CUSTOMER WAS NOT TREATED AND WAS DISCHARGED THE SAME DAY. CUSTOMER WAS ADVISED TO OBTAIN A NEW METER.

    Description of Event or Problem · 1

    CUSTOMER HAD CALLED IN REFERENCE TO REPORT NUMBER (B)(4), STATING SHE HAD PURCHASED REPLACEMENT TEST STRIPS, LOT MX4434S, MANUFACTURER¿S EXPIRATION DATE OF 07/31/2022. CUSTOMER REPORTED SHE WAS STILL OBTAINING LOW BLOOD GLUCOSE TEST RESULTS USING THE NEW TEST STRIPS. CUSTOMER WAS CONCERNED WITH RESULT OBTAINED OF 64MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED HAVING A LIGHT HEADACHE. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER STATED SHE WAS GOING TO EAT AND DECLINED FURTHER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600272 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC METER, TRUE METRIXMETER ONLY MG/DL MX4434S 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization