BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2854423 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-91019
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PRIME ALARM DURING BASIC OCCLUSION TEST DUE TO LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM OCCLUSION, PRIME AND NO DELIVERY TESTS DUE TO PRIME ALARMS DURING BASIC OCCLUSION TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED. DURING THE CALL THE NURSE STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND NOTHING FURTHER WAS GIVEN AT THE TIME. ATTEMPTED TO CONTACT THE CUSTOMER LATER AND HE STATED THAT HE EXPERIENCED HIGH BLOOD GLUCOSE AS A RESULT OF TREATING WITH A BACK UP PLAN AFTER HE WAS TOLD TO DISCONNECT DUE TO THE ALARM. THE CUSTOMER WAS DISCONNECTED FOR TWENTY TWO HOURS PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE AT TIME OF HIS ADMISSION WAS OVER 500MG/DL, AND HIS BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization