BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984075 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91447
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 THAT THE INSULIN PUMP WAS NOT FUNCTIONING AND HIS BLOOD GLUCOSE WENT OVER 600MG/DL. THE CUSTOMER STATED THAT THE DEVICE ALARMED NO DELIVERY AND MOTOR ERROR. THE CUSTOMER STATED THAT HE MIGHT HAVE TO GO TO THE EMERGENCY ROOM. THE CUSTOMER MENTIONED BEING AWAY FROM HOME AND FEELS SICK. THE CALLER WAS DRIVING AND DID NOT HAVE SUPPLIES. ADVISED THE CUSTOMER TO CALL BACK TO TROUBLESHOOT. ATTEMPTED TO CALL THE CUSTOMER SEVERAL TIMES TO GET MORE DETAILS ON THE HOSPITALIZATION WITH NO RESULTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88050 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 43 YR Hospitalization