BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM CONTINUOUS GLUCOSE MONITOR

    MDR report key: 5554249 · Received April 6, 2016

    Report

    Report Number
    MW5061543
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    March 29, 2016
    Report Date
    April 6, 2016
    Manufacturer
    DEXCOM
    Product Code
    MDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING HIS DEXCOM CONTINUOUS GLUCOSE MONITOR. PATIENT SAID HE HAS BEEN USING THE MONITOR SINCE (B)(6) 2016, BUT ON (B)(6) 2016, HE WAS TAKEN BY RESCUE TO THE EMERGENCY ROOM WITH A LOW BLOOD GLUCOSE LEVEL OF 29MG. PATIENT STATED HIS MONITOR FAILED TO ALERT HIM OF THE LOW, AND MISSED THE URGENT ALERT THAT SHOULD HAVE ALARMED AT 50MG. PATIENT STATED THAT ON THE SAME DAY HE WAS TAKEN BY RESCUE, HIS PARENTS HAD PICKED UP AN URGENT CERTIFIED LETTER FOR HIM, WHICH ENDED UP BEING FROM DEXCOM. HE SAID THE LETTER FROM DEXCOM WAS INFORMING HIM OF ISSUES WITH THE MONITOR'S ALARM AND FAILING TO ALERT PROPERLY. PATIENT SAID THE LETTER GAVE A NUMBER TO CALL FOR TECH SUPPORT, BUT PATIENT HAS BEEN UNABLE TO GET INTO CONTACT WITH ANYONE. HE STATED HE HAS CALLED 8 TIMES AND STAYED ON HOLD FOR AT LEAST AN HOUR EACH TIME, AND WAS PROMPTED TO LEAVE HIS PHONE NUMBER AND RECEIVE A CALL BACK WITHIN 24 HOURS. HE IS STILL WAITING TO HEAR BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205895 DEXCOM CONTINUOUS GLUCOSE MONITOR DEXCOM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization