BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2182438 · Received July 18, 2011

    Report

    Report Number
    3004209178-2011-82183
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS INSULIN PUMP WAS EXPOSED TO WATER. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD BLANK DISPLAY, AND IT IS BEEPING. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THERE IS WATER UNDER THE SCREEN. ADVISED CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. THEN THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED AND TOOK HIM TO THE HOSPITAL. THE CUSTOMER STATED THAT HE WAS ADMITTED DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE READING WAS 370MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. 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 MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization