BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2233960 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82806
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 609MG/DL. THE CUSTOMER STATED CHANGING SEVERAL INFUSION SETS. THE CUSTOMER STATED HAVING ISSUES WITH NO DELIVERY ALARM DURING BOLUS, FIXED PRIME, AND ONCE DURING MANUAL PRIME. THE CUSTOMER STATED THAT SHE REMOVED THE INFUSION SET AND RAN THE SAME PROCESS AND GOT NO DELIVERY ALARM DURING FIXED PRIME. THE CUSTOMER WAS NOT ABLE TO TROUBLESHOOT THE INSULIN PUMP BECAUSE SHE DID NOT HAVE ANY SUPPLIES WITH HER. THE CUSTOMER STATED THAT SHE IS UNCOMFORTABLE USING THE DEVICE AND REQUESTED A REPLACEMENT OF THE INSULIN PUMP. 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-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization