BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171120 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82110
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 599 MG/DL. THE CUSTOMER STATED THAT SHE WAS SWEATING AND PASSED OUT. THE CUSTOMER EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST MONTH. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 148 MG/DL AND WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. THE CUSTOMER SOMETIMES DOES HAVE BENT CANNULAS. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TEST. 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 57 YR Hospitalization QUICK-SET, 23| (B)(4) INFUSION SET: MMT-397| PARADIGM, 9MM CATHETER