BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN REAL-TIME MONITIOR

    MDR report key: 4140801 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32751
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED AN ERROR ALARM AND HAD A BLANK DISPLAY. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620128 GUARDIAN REAL-TIME MONITIOR CGM MDS MEDTRONIC MINIMED CSS7100WW

    Patients

    Seq Age Sex Outcome Treatment
    1