BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082824 · Received April 28, 2011

    Report

    Report Number
    3004209178-2011-81245
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 AND DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 661MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP IS CORRECT. RAN SELF TEST, PRIME AND HIGH PRESSURE TEST AND THE DEVICE PASSED THE TESTS. THE CUSTOMER STATED THAT SHE CHANGES THE INFUSION SET EVERY THREE TO FOUR DAYS. ADVISED THE CUSTOMER THAT SHE NEEDS TO CHANGE THE INFUSION SET EVERY TWO TO THREE DAYS. THE CUSTOMER STATED THAT SHE FELT HER SINUS INFECTION MAY HAVE LEAD TO HER HOSPITALIZATION. THE CUSTOMER STATED THAT THE DAY BEFORE TO HER ADMISSION, SHE WAS VERY SICK THROWING UP AND DID NOT CHECK HER GLUCOSE LEVEL. 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 49 YR Hospitalization