BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3022983 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-92133
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    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 RUSHED TO THE EMERGENCY ROOM BECAUSE SHE OVERDOSED 40.0 UNITS OF INSULIN. THE CUSTOMER STATED THAT HER ADMISSION HAS NOTHING TO DO WITH THE INSULIN PUMP. THE CUSTOMER MENTIONED HAVING ISSUES CALIBRATING. THE CALLER STATED THAT SHE CALIBRATED ONCE, BUT IT DID NOT SHOW UP IN THE HISTORY. EXPLAINED TO THE CUSTOMER THAT IT TAKES 15 MINUTES FOR THE CALIBRATION TO SHOW UP IN THE HISTORY. ADVISED THE CALLER TO CALL BACK IF ISSUES PERSIST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127222 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 53 YR Hospitalization