BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE CD-ROM CARELINK PRO EN

    MDR report key: 4230782 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48248
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE INFORMATION ON THE INSULIN PUMP COULD NOT BE UPLOADED; CUSTOMER WAS BEING ASSISTED BY THE NURSE AT THE HOSPITAL. IT WAS STATED THAT THE CUSTOMER WAS CALIBRATING THE INSULIN PUMP BUT NOTHING COULD BE FOUND. IT WAS STATED THAT THE DEVICE ALARMED FAILED SELF TEST. CUSTOMER TRIED MULTIPLE PORTS ON THE COMPUTER. IT WAS FOUND THAT THE REASON IT FAILED WAS BECAUSE OF THE INSULIN PUMP HAD THE ERROR ALARMS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714581 SOFTWARE CD-ROM CARELINK PRO EN CGM MDS MEDTRONIC MINIMED MMT-7335

    Patients

    Seq Age Sex Outcome Treatment
    1