BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2962341 · Received February 14, 2013

    Report

    Report Number
    2032227-2013-00606
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND A SEIZURE. THE CALLER STATED THAT THE PARAMEDICS WERE CALLED, AND THE CUSTOMER'S BLOOD GLUCOSE WAS 20 MG/DL WHEN THEY ARRIVED. THE CALLER STATED THAT THE CUSTOMER HAD GIVEN HIMSELF A BOLUS PRIOR TO THE EVENT, BUT IT WAS NOT ENOUGH INSULIN TO MAKE HIS BLOOD GLUCOSE LEVELS DROP BY THAT MUCH. THE CALLER ALSO STATED THAT THE CUSTOMER'S SENSOR GLUCOSE READINGS HAVE BEEN OFF BY 50 POINTS. TROUBLESHOOTING WAS NOT POSSIBLE AS THE CUSTOMER WAS NOT PRESENT AT THE TIME OF THE CALL. ADVISED THE CALLER TO HAVE THE CUSTOMER CALL BACK FOR TROUBLESHOOTING AT HIS CONVENIENCE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65260 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention