BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS GLUCOSE MONITOR

    MDR report key: 14163951 · Received April 20, 2022

    Report

    Report Number
    3004753838-2022-062807
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    February 20, 2022
    Report Date
    April 20, 2022
    Product Code
    QBJ
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A2: DATE OF BIRTH - CORRECTION A3: GENDER - CORRECTION B3: DATE OF EVENT - CORRECTION B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION D3: MFG POSTAL CODE - CORRECTION D9: DEVICE AVAILABILITY - ADDITIONAL INFORMATION E1: INITIAL REPORTER INFO - CORRECTION E1: INITIAL REPORTER LAST NAME: CINTRON-RODRIGUEZ G1: CONTACT OFFICE CONTINUED - CORRECTION H2: ADDITIONAL INFORMATION / DEVICE EVALUATION H3: CORRECTION / DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL INFORMATION H6: ADVERSE EVENT PROBLEM - ADDITIONAL INFORMATION THE SUPPLEMENTAL MDR -01 FOLLOW UP CORE ID: CI1650319277783.4296285@FDSLV86001_TE2 MFR: 3004753838-2022-040530-01 WAS SUBMITTED 4/14/22 (DAY 24) AND FAILED IT¿S THIRD ACK WITH AN ERROR SAYING THAT THE INITIAL REPORT IS MISSING. THE INITIAL MDR CORE ID: CI1647514824009.7576412@FDSLV86001_TE1 MFR: 3004753838-2022-040530 WAS SUBMITTED 3/17/22 AND RECEIVED ALL ITS PASSING ACKS AND WAS SUCCESSFULLY CLOSED AND COMPLETED. I DOUBLE CHECKED THAT IT HAD THE SAME MFR AND COREID AS WELL. WE RESUBMITTED SUPPLEMENTAL MDR -01 FOLLOW UP CORE ID: CI1650319277783.4296285@FDSLV86001_TE2 MFR: 3004753838-2022-040530-01 A SECOND TIME ON 4/18/22 (DAY 28) BUT FAILED DUE TO THE SAME REASON. WE ARE USING A NEW MFR FOR THIS SUBMISSION BUT THIS IS STILL RELATED TO THE ORIGINAL INITIAL MDR CORE ID: CI1647514824009.7576412@FDSLV86001_TE1 MFR: 3004753838-2022-040530.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. PERFORMED VOLTAGE TEST AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666950 CONTINUOUS GLUCOSE MONITOR QBJ

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female