BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090117 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81361
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 27 MMOL/L. IT WAS STATED THAT THE DAY BEFORE, THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR TWICE, AND BOTH CANNULAS LOOK FINE. IT WAS STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY. IT WAS STATED THAT THE CUSTOMER STARTED VOMITING. THE CUSTOMER CONTACTED THE DOCTOR AND THEN WENT TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY REVEALED A LOW RESERVOIR AND NO DELIVERY ALARM. 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-522WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization