BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2902410 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-90133
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 DUE TO HIGH BLOOD GLUCOSE OF 419MG/DL. THE CALLER STATED THAT SHE ALSO HAD STOMACH FLU. THE EVENTS LEADING TO HER ADMISSION WAS DIABETES KETOACIDOSIS, URINARY TRACT INFECTION, AND DEHYDRATION. TROUBLESHOOTING WAS PERFORMED. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 144MG/DL, AND HER BLOOD GLUCOSE WAS TREATED WITH THE INSULIN PUMP AND 8.0 UNITS OF INSULIN. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND SELF TEST AND THEY PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9552 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization UNOMEDICAL INFUSION SET