BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2891771 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-91640
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    December 8, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 REPORTED BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 813MG/DL, AND HIS BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS HIGH THE NIGHT BEFORE AND WAS FOUND THAT HE HAS KIDNEY INFECTION. THE CALLER MENTIONED RECEIVING NO DELIVERY ALARMS DURING BOLUS. ASSISTED THE CUSTOMER TO RUN A FIXED PRIME TEST AND THE INSULIN DID EXIT. INSTRUCTED THE CALLER TO REMOVE THE CANNULA AND IT WAS BENT. SUGGESTED THE CUSTOMER TO CHANGE THE INFUSION SET AND RESERVOIR EVERY TWO TO THREE DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization