BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE

    MDR report key: 4123418 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29672
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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 WAS CALLING FOR ASSISTANCE WITH UPLOADING THE INFORMATION OF THEIR INSULIN PUMP ONTO THEIR ONLINE ACCOUNT. UPON REVIEWING THE HISTORY OF THE INSULIN PUMP IT WAS DISCOVERED THAT THERE WERE MULTIPLE ERROR ALARMS THAT HAD REOCCURRING. THE CUSTOMER WAS ADVISED THAT THE DEVICE NEEDED TO BE CHANGED. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602236 SOFTWARE CGM MDS MEDTRONIC MINIMED MMT-7335

    Patients

    Seq Age Sex Outcome Treatment
    1