BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2062697 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81002
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. 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 HYPERGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 17 MMOL/L. THE CUSTOMER STATED THAT PRIOR TO THE HOSPITALIZATION, HE DID NOT PRIME THE INSULIN PUMP PROPERLY WHEN HE CHANGED HIS INFUSION SET, WHICH RESULTED IN HIM MISSING 14 UNITS OF INSULIN AND ELEVATED BLOOD GLUCOSE LEVELS RANGING FROM 20 TO 27 MMOL/L. THE CUSTOMER ALSO STATED THAT HE TREATED FOR THE HIGH BLOOD GLUCOSE LEVELS WITH MANUAL INJECTIONS AND CHANGED HIS INFUSION SET, BUT THE ELEVATED BLOOD GLUCOSE LEVELS PERSISTED. THE CUSTOMER THEN STATED THAT THIS IS WHEN HE WENT TO THE HOSP FOR TREATMENT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE 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-522WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization