BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2019-020386

    MDR report key: 8364742 · Received February 24, 2019

    Report

    Report Number
    3004753838-2019-020386
    Event Type
    Malfunction
    Date Received
    February 24, 2019
    Date of Event
    October 9, 2018
    Report Date
    February 22, 2019
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2019, THAT ON DOI, A PAIRING FAILURE BETWEEN TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW DID NOT CONFIRM THE REPORTED EVENT OF PAIRING FAILURE. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED ISSUE OF PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF PERMANENT CONNECTION LOSS.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 02-02-2019, THAT ON DOI, A PAIRING FAILURE BETWEEN TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW COULD NOT DETERMINE THE REPORTED EVENT OF PAIRING FAILURE. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED ISSUE OF PAIRING FAILURE IS NOT REPORTABLE ANYMORE AFTER DATA REVIEW. INITIALLY, THE MEDWATCH STATED THE COMPLAINT WAS REPORTABLE DUE TO INCORRECTLY REVIEWING THE DATA.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR