BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2200794 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-82379
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE OF 400MG/DL. IT WAS STATED THAT THE INFUSION SET WAS CHANGED, BUT THE CUSTOMER'S GLUCOSE LEVEL CONTINUED BEING HIGH. TROUBLESHOOTING WAS PERFORMED. THE DAILY TOTALS MATCHED TO THE BASAL AND BOLUS. PROGRAMMED A BOLUS AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND PASSED. THE TIME, DATE, AND PROGRAMMING ON THE INSULIN PUMP WERE CORRECT. DURING THE CALL THE CUSTOMER MENTIONED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER DEVELOPED KETONES RAPIDLY, FREQUENTLY CHANGED THE INFUSION SET, AND TREATED WITH THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER HAD SYMPTOMS OF NAUSEA AND VOMITING. IT WAS STATED THAT AFTER CHANGING THE INFUSION SET THE CUSTOMER NOTICED THE CANNULA WAS BENT. 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-522WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization