BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-011451

    MDR report key: 7235498 · Received February 2, 2018

    Report

    Report Number
    3004753838-2018-011451
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 31, 2018
    Report Date
    January 31, 2018
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A LOSS OF CONNECTION COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR