BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3110043 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01923
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    THE CUSTOMER CALLED TO REPORT A NO DELIVERY ALARM AND BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL, WHICH WERE TREATED WITH A MANUAL INJECTION. THE CUSTOMER ALSO STATED THAT SHE EXPERIENCED A LOW BLOOD GLUCOSE OF 40 MG/DL YESTERDAY, AND FELT THAT THE INSULIN PUMP GAVE HER TOO MUCH INSULIN. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE LOW BLOOD GLUCOSE LEVELS, BUT DID CONDUCT TROUBLESHOOTING FOR THE NO DELIVERY ALARM. THE INSULIN PUMP PASSED THE PRIME TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WAS WORKING PROPERLY, AND THE ALARM WAS DUE TO AN OCCLUSION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210487 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR