BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984130 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91486
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 HAVING AN URGENT CARE VISIT DUE TO HER HIGH BLOOD GLUCOSE OF 382MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER EXPERIENCED HEADACHES AND NAUSEA. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER WITH CORRECTING THEM. THE BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND LOW RESERVOIR AND NO DELIVERY ALARMS. INSTRUCTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88173 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization