BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4078898 · Received September 10, 2014

    Report

    Report Number
    2032227-2014-20104
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 CUSTOMER HAD A POTENTIAL OVER-INFUSION. CUSTOMER WANTED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 185 MG/DL. CUSTOMER WAS DISCONNECTED DURING THE REWIND/PRIME SEQUENCE WHEN SET WAS CHANGED ON 07/19/2104. PROGRAMMING WAS REVIEWED AND SETTINGS WERE FOUND TO BE ACCURATE. CUSTOMER WAS ADVISED TO SPEAK WITH HIS HEALTH CARE PROFESSIONAL REGARDING THE LOW BLOOD GLUCOSE LEVELS. CUSTOMER ADVISED TO MONITOR THE PUMP AND CALL BACK IF ISSUES PERSIST. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557935 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB A000114649

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR