BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2233954 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82799
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 200 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND THE TEST PASSED. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP FAILED THE TEST. ADVISED THE CUSTOMER THAT A REPLACEMENT OF THE INSULIN PUMP WILL BE SENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization MIO SET 23", 6MM BLUE| UNOMEDICAL INFUSION SET: MMT-943