BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 8546862 · Received April 24, 2019

    Report

    Report Number
    1000113657-2019-00388
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 29, 2019
    Report Date
    May 6, 2020
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007720
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) SECTIONS WITH ADDITIONAL INFORMATION AS OF 06-MAY-2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION 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 AND PASSED. INTERNAL REPORT (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. TEST STRIP UDI.(B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 198, 190, 321 AND 340 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 106 - 125 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SOMETIME IN THE BEGINNING OF MARCH, BETWEEN THE 7TH OR THE 10TH, HE HAD CHECKED HIS BLOOD SUGAR AROUND 7:00PM AND THE RESULT OBTAINED WAS IN THE 260SMG/DL (CUSTOMER DID NOT REMEMBER THE EXACT DETAILS) CUSTOMER STATED THAT BASED ON THE RESULT, HE TOOK (B)(4) UNITS OF HIS INSULIN AND WENT TO SLEEP. CUSTOMER STATED THAT HE FELL INTO DEEP SLEEP. CUSTOMER STATED THE NEXT DAY, HE WAS STILL ASLEEP WHEN THE CAREGIVER CAME IN AT 11:00AM, TO FIND THE CUSTOMER UNRESPONSIVE. CAREGIVER WAS NOT ABLE TO WAKE THE CUSTOMER UP AND SHE CALLED 911. WHEN THE PARAMEDICS ARRIVED, THEY WERE ABLE TO WAKE THE CUSTOMER UP AND PERFORMED A BLOOD GLUCOSE TEST USING THEIR METER AND OBTAINED A RESULT OF 48MG/DL FASTING. CUSTOMER WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. CUSTOMER STATED THAT AT THE HOSPITAL HE WAS CONSCIOUS AND HE DID NOT REMEMBER DETAILS (HE DID NOT REMEMBER HIS DIAGNOSIS, TREATMENT GIVEN OR HIS BLOOD GLUCOSE TEST RESULTS WHILE THERE). CUSTOMER STATED HE WAS RELEASED TWO DAYS LATER (DOES NOT REMEMBER THE EXACT DATE) AND THAT THEY MADE CHANGES TO HIS INSULIN BY REDUCING IT. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 288 MG/DL USING METER. CUSTOMER DECLINED TO PERFORM A SECOND BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 198MG/DL DATE: (B)(6) 2019 TIME: 6:53PM FASTING, RESULT 2 : 190MG/DL DATE: (B)(6) 2019 TIME: 5:53PM FASTING, RESULT 3 : 102MG/DL DATE: (B)(6) 2019 TIME: 8:41AM FASTING, RESULT 4 : 321MG/DL DATE: (B)(6) 2019 TIME: 7:28PM FASTING, RESULT 5 : 340MG/DL DATE: (B)(6) 2019 TIME: 5:38PM FASTING.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 198, 190, 321 AND 340 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 106 - 125 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SOMETIME IN THE BEGINNING OF (B)(6), BETWEEN (B)(6) OR (B)(6), HE HAD CHECKED HIS BLOOD SUGAR AROUND 7:00PM AND THE RESULT OBTAINED WAS IN THE 260SMG/DL (CUSTOMER DID NOT REMEMBER THE EXACT DETAILS) CUSTOMER STATED THAT BASED ON THE RESULT, HE TOOK 27 UNITS OF HIS INSULIN AND WENT TO SLEEP. CUSTOMER STATED THAT HE FELL INTO DEEP SLEEP. CUSTOMER STATED THE NEXT DAY, HE WAS STILL ASLEEP WHEN THE CAREGIVER CAME IN AT 11:00AM, TO FIND THE CUSTOMER UNRESPONSIVE. CAREGIVER WAS NOT ABLE TO WAKE THE CUSTOMER UP AND SHE CALLED 911. WHEN THE PARAMEDICS ARRIVED, THEY WERE ABLE TO WAKE THE CUSTOMER UP AND PERFORMED A BLOOD GLUCOSE TEST USING THEIR METER AND OBTAINED A RESULT OF 48MG/DL FASTING. CUSTOMER WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. CUSTOMER STATED THAT AT THE HOSPITAL HE WAS CONSCIOUS AND HE DID NOT REMEMBER DETAILS (HE DID NOT REMEMBER HIS DIAGNOSIS, TREATMENT GIVEN OR HIS BLOOD GLUCOSE TEST RESULTS WHILE THERE). CUSTOMER STATED HE WAS RELEASED TWO DAYS LATER (DOES NOT REMEMBER THE EXACT DATE) AND THAT THEY MADE CHANGES TO HIS INSULIN BY REDUCING IT. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 288 MG/DL USING METER. CUSTOMER DECLINED TO PERFORM A SECOND BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2020 AND OPEN VIAL DATE IS FEBRUARY 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339462 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MV3197 00021292007720

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization SECOND THERAPY| SECOND THERAPY