BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2902228 · Received January 8, 2013

    Report

    Report Number
    2032227-2013-00051
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 15, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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 CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 469 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP HAD THE CORRECT TIME AND DATE. THE CALLER STATED THAT THE CUSTOMER WAS NOT SURE WHETHER OR NOT THE BASAL RATES WERE CORRECT. FOUND NO DELIVERY ALARMS IN THE ALARM HISTORY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. IT WAS STATED THAT THE CUSTOMER NORMALLY INSERTS THE INFUSION SET IN HIS ABDOMEN, AND MAY HAVE SCAR TISSUE. THE CUSTOMER WAS SENT SAMPLES OF OTHER INFUSION SETS TO TRY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9598 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization