BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6898758 · Received September 27, 2017

    Report

    Report Number
    1000113657-2017-01752
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 27, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007911
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # 01509810 PRODUCT NOT RETURNED FOR EVALUATION. NO REPLACEMENT PRODUCT NEEDED AT THIS TIME. COMPLAINT RESOLVED BY TRAINING DURING THE TIME OF THE CALL. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE. (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-5 AND HI ACCOMPANIED BY SYMPTOMS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH THE RESULT OF E-5 AND HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FATIGUE AND SLIGHT NAUSEA. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 145MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6) 2018 AND OPEN VIAL DATE IS APPROXIMATELY 1-2 WEEKS AGO. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. MOTHER OF A (B)(6) DIABETIC IS CALLING DUE TO GETTING AN E-5 AFTER THE BLOOD IS APPLIED TO THE STRIPS. SHE IS CALLING FOR HER SON. HE IS NOT FEELING WELL HE IS VERY FATIGUED. EARLIER HE WAS NAUSEATED BUT HE IS FEELING BETTER. THE MOTHER USE THE METER AND STRIPS ON HER SON AND SHE WAS ABLE TO GET A BLOOD READING OF 145MG/DL NON-FASTING. MOTHER LATER RETEST HER SON AND THE METER IS NOW READING HI BUT HE NOW JUST ATE WITHIN 2 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677798 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT2285 00021292007911

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR