BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR BSA

    MDR report key: 3120997 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-02012
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    THE CUSTOMER CALLED TO REPORT THAT HE HAD AN ALLERGIC REACTION TO THE PLASTIC AROUND THE ELECTRODE, AND ENDED UP IN THE HOSPITAL WITH DIZZINESS, ACHY JOINTS AND CONFUSION. THE CUSTOMER STATED HE WAS VERY PALE. THE CUSTOMER STATED THAT HE IS ALLERGIC TO TEFLON, AND WANTED TO KNOW IF THE PRODUCT HAD TEFLON ON IT. CONTACTED THE CUSTOMER, AFTER RESEARCHING, AND ADVISED HIM THE MATERIAL IS POLYURETHANE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222530 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C B283

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization