BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082823 · Received April 28, 2011

    Report

    Report Number
    3004209178-2011-81260
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 326MG/DL. IT WAS STATED THAT THE NURSE BELIEVES THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. A DAY LATER, THE CUSTOMER CALLED BACK TO TROUBLESHOOT THE DEVICE. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND BOTH TESTS PASSED. IT WAS STATED THAT THE CUSTOMER WILL CONTINUE ON BACK UP PLAN UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization