BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2973132 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-91235
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CUSTOMER EXPERIENCED SHORTNESS OF BREATH AND VOMITING. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL NO DELIVERY ALARMS. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. THE CALLER STATED THAT THE CANNULA WAS BENT WHEN HE REMOVED THE INFUSION SET. THE CUSTOMER INSERTED IN THE HIP AREA, AND HE BELIEVES THAT HE MAY INSERT NEAR THE HIP BONE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75514 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 64 YR Hospitalization