BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3191831 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95127
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 WITH KETOACIDOSIS, AND THE INSULIN PUMP WAS NOT DELIVERING THE INSULIN. THE CUSTOMER WAS ILL, HAD NAUSEA, PAIN IN THE UPPER ABDOMEN, AND HAD TROUBLE BREATHING. THE BLOOD GLUCOSE READING WAS 28MG/DL BY THE TIME THE PARAMEDICS ARRIVED. IT WAS STATED THAT THE CUSTOMER WAS CHECKING THE BLOOD GLUCOSE CONSTANTLY AND GIVING SPONTANEOUS BOLUSES. IT WAS STATED THAT SHE WOKE UP WITH HIGH BLOOD GLUCOSE AND DID FEEL SICK. THE CUSTOMER TREATED AND ATE BREAKFAST, AND THEN SHE FELT SICK. IT WAS STATED THAT THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST, BUT THE INSULIN DID NOT EXIT. IT WAS STATED THAT THE INFUSION SET WAS CHANGED DUE TO THE HIGH GLUCOSE LEVEL AND NOTICED THAT THE TUBING WAS CRACKED. IT WAS STATED THAT THE CUSTOMER REMOVED THE SKIN AND NOTICED A CRACK ON THE INSULIN PUMP. IT WAS STATED THAT SHE STOPPED USING THE DEVICE FOR SOME TIME AND KEPT IN A DRAWER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289726 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization