BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR BSA

    MDR report key: 3120988 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-01999
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER INSERTED A SENSOR, AND BEGAN BLEEDING. IT WAS STATED THAT THE CUSTOMER GOT LIGHT HEADED AND PASSED OUT FOR A WHILE, THEN WENT TO THE EMERGENCY ROOM. PRIOR TO PASSING OUT, HIS BLOOD GLUCOSE WAS 129 MG/DL. ONCE HE REGAINED CONSCIOUSNESS HE WAS AT 74 MG/DL. THE CUSTOMER WAITED IN THE EMERGENCY ROOM FOR SIX HOURS BUT DIDN'T RECEIVED TREATMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222580 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization