BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082786 · Received April 28, 2011

    Report

    Report Number
    3004209178-2011-81269
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 17, 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 Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE TWO DAYS AGO. IT WAS STATED THAT THE CUSTOMER DID NOT GIVE ANY MANUAL INJECTION AS HE THOUGHT THE PROBLEM HE WAS HAVING WAS CHEST PAIN, HENCE HE WAS ADMITTED TO HOSPITAL. IT WAS STATED THAT THE CUSTOMER WEARS THE INFUSION SET FOR THREE DAYS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING OF THE INSULIN PUMP WAS CORRECT. 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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization