BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4173656 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38291
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ANALYSIS NOT REQUIRED AS THE SENSORS RECEIVED WERE EXPIRED. NO NEEDLE BREAK ANOMALY COULD BE VERIFIED AS ONLY THE SEALED SENSORS WERE RETURNED AND NOT THE USED SENSORS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SENSOR NEEDLE BROKE ON TWO OCCASIONS DURING INSERTION. CUSTOMER STATED THAT SHE THOUGH THE SENSORS MIGHT BE BAD BUT NOW SHE THINKS THAT THE SERTER COULD NOT BE INSERTING PROPERLY. CUSTOMER STATED THAT THE NEEDLE WAS BROKEN AT THE TIP AND ONE PORTION OF THE CANNULA PILLED BACK ABOUT 1/16 OF AN INCH. THE SENSOR WAS INSERTED ON THE LEFT SIDE OF THE ABDOMEN. THE NEEDLE WAS NOT HARD TO REMOVE, BUT IT WAS PAINFUL. CUSTOMER PULLED THE SENSOR OUT AND IT ALL CAME OUT IN ONE PIECE; IT IS NO LONGER IN HER BODY. CUSTOMER STATED THAT THERE IS NO PAIN OR IRRITATION ON THE SITE CURRENTLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654984 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C D234

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR