BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11887039 · Received May 26, 2021

    Report

    Report Number
    1000113657-2021-00331
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 17, 2021
    Report Date
    June 29, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 29-JUN-2021: H10: METER WAS NOT RETURNED FOR EVALUATION. 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-062: USER HAD POOR TECHNIQUE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER DECLINED. REPLACEMENT (COURTESY VIAL OF TEST STRIPS HAD BEEN SENT). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 19-MAY-2021 TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HE NO LONGER HAD THE TRUE METRIX METER AND WAS NO LONGER USING THE TRUE METRIX PRODUCTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-0). CUSTOMER STATED HE HAD OBTAINED THE E-0 ERROR MESSAGE 15 TIMES. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2021 AND OPEN VIAL DATE IS (B)(6) 2021. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER THAT PRODUCED A BLOOD GLUCOSE TEST RESULT, WHICH WAS NOT DISCLOSED BY THE CUSTOMER; CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT HE HAD BEEN HOSPITALIZED ON (B)(6) 2021 DUE TO HIS DIABETES, AND HAD BEEN DISCHARGED (B)(6) 2021. CUSTOMER STATED HIS INSULIN HAD BEEN INCREASED AND HE HAD BEEN TRAINED ON CHECKING HIS BLOOD GLUCOSE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783176 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, TMX GNP METERMG/DL MX4318S 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization