BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4103237 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26493
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE BOLUS PROCEDURE. THE CUSTOMER STATED THAT THIS WAS THE SECOND TIME THE DEVICE HAD THIS ISSUE SINCE IT FIRST HAPPENED 4 DAYS PRIOR. THE BLOOD GLUCOSE READING WAS 174 MG/DL. UPON TROUBLESHOOTING, IT WAS FOUND THAT INSULIN DID EXIT DURING A FIXED PRIME. EXPLAINED THAT THERE MAY HAVE BEEN A POSSIBLE INSERTION SITE-RELATED ISSUE, POSSIBLY DUE TO A BENT CANNULA OR OCCLUSION. ADVISED THE CUSTOMER TO PERFORM A COMPLETE INFUSION SET CHANGE. THE CUSTOMER AGREED AND STATED THAT HE WOULD MONITOR AND CALL BACK IF NEEDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582169 INSULIN INFUSION PUMP CGM MDS MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR