BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4141826 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33607
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    CUSTOMER STATED THE BATTERY ON HER INSULIN PUMP WOULD GO OUT. SHE STATED SHE WAS INSTRUCTED TO PRESS ACT BUT THE ISSUE PERSISTS. THE CUSTOMER ALSO REPORTED A CRACK ON HER INSULIN PUMP'S SCREEN. THE CUSTOMER STATED THE CRACK MADE IT HARD FOR HER TO READ THE INSULIN PUMP'S SCREEN. THE CUSTOMER WAS ADVISED TO HAVE HER INSULIN PUMP REPLACED. CUSTOMER'S BLOOD GLUCOSE WAS 187 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621595 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR