BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2823246 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-90604
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE, AND HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN PEN. THE CUSTOMER STATED THAT SHE EXPERIENCED URINARY PROBLEMS AND KIDNEY INFECTION. THE TIME AND DATE ON THE DEVICE WERE INCORRECT. ASSISTED THE CALLER TO CORRECT THEM. THE CUSTOMER STATED THAT SHE IS UNSURE OF LAST BOLUS SINCE SHE HAS BEEN DISCONNECTED FROM THE DEVICE SEVERAL DAYS PRIOR TO HER ADMISSION. ASSISTED THE CALLER TO RUN THE MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE CUSTOMER MENTIONED ALSO RECEIVING NO DELIVERY ALARMS WHILE RUNNING THE MANUAL PRIME. THEN THE CALLER CHANGED THE RESERVOIR AND RAN THE MANUAL PRIME AGAIN, AND IT PASSED. AFTER THE CUSTOMER RECEIVED THE TUBING CLAMP, SHE CALLED BACK TO PERFORM THE HIGH PRESSURE TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization