BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2020050 · Received March 9, 2011

    Report

    Report Number
    3004209178-2011-80584
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 WITH A HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL. THE CUSTOMER STATED THAT FOUR HOURS PRIOR TO THE EVENT, SHE HAD CHANGED HER INFUSION SET. THE CUSTOMER ALSO STATED THAT SHE CHANGES HER INFUSION SET EVERY 3 DAYS AND INSERTS IN HER ABDOMEN. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE FIXED PRIME AND HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    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-722WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization