BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984101 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91479
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 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 GETTING NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE ALARMS OCCURRED DURING MANUAL PRIME. ADVISED THE CUSTOMER TO INSERT THE RESERVOIR INTO THE DEVICE AND TO RUN THE MANUAL PRIME TEST, BUT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. THE CUSTOMER DECLINED TO CONTINUE TESTING AND STATED THAT SHE HAS BEEN HOSPITALIZED TWICE IN THE PAST DUE TO BENT CANNULAS. THE CALLER STATED THAT HER BLOOD GLUCOSE WENT OVER 600MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86547 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization