BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 11609203 · Received April 2, 2021

    Report

    Report Number
    1000113657-2021-00225
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 7, 2021
    Report Date
    May 10, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 10-MAY-2021: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. 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

    (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 10-MAR-2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE WAS NO LONGER EXPERIENCING SYMPTOMS; NO FURTHER MEDICAL ATTENTION WAS REPORTED. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 22-MAR-2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-5). CUSTOMER WAS USING THE PROPER TESTING TECHNIQUES. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/29/2022 AND TEST STRIPS WERE OPENED TWO MONTHS PRIOR TO CALL. THE CUSTOMER DECLINED TO PERFORM A BLOOD TEST DURING THE CALL, STATING THAT SHE ONLY HAD ONE TEST STRIP LEFT. THE CUSTOMER REPORTED FEELING WEAK AND DIZZY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED THAT SHE HAD CALLED THE AMBULANCE ON (B)(6) 2021 DUE TO FEELING THAT HER BLOOD GLUCOSE LEVEL AND BLOOD PRESSURE HAD BEEN HIGH. CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN THE PARAMEDICS HAD ARRIVED HAD BEEN 170 MG/DL USING THEIR METER (FASTING/NON-FASTING STATUS UNKNOWN). CUSTOMER HAD BEEN DIAGNOSED WITH HYPERGLYCEMIA AND HIGH BLOOD PRESSURE. CUSTOMER WAS NOT TAKEN TO THE HOSPITAL; CUSTOMER HAD TAKEN MEDICATION (GLIPIZIDE) AND HAD FELT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504988 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZX4210S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention