BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7002C,10PK, GLUCOSE, BSA,17L

    MDR report key: 2243232 · Received September 1, 2011

    Report

    Report Number
    2032227-2011-02227
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SENSOR ELECTRODE BROKE OFF UNDERNEATH THE SKIN AS HE ATTEMPTED TO REMOVE IT. INITIALLY, THE SENSOR HAD NOT INSERTED COMPLETELY IN THE SKIN. THE CUSTOMER PUSHED DOWN ON IT AND HE HEARD A SNAP. WHEN REMOVED IT, HE NOTICED WHAT HAD HAPPENED. THE CUSTOMER STATED THAT HE CAN SEE A PUMP. ADVISED THE CUSTOMER THAT THE SENSOR WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR MMT-7002C,10PK, GLUCOSE, BSA,17L GLUCOSE SENSOR (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7002C F291

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR