BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2912227 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-90223
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARMS DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING DISPLACEMENT, PRIME, BASIC OCCLUSION, OCCLUSION AND NO DELIVERY TESTS DUE TO MOTOR ERROR ALARMS DURING REWIND. THE INSULIN PUMP HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE OVER 500MG/DL. THE CALLER STATED THAT THE CUSTOMER HAD A DIABETIC ULCER ON THE RIGHT BIG TOE. THE SPOUSE ALSO STATED THAT THE CUSTOMER HAD SEIZURES AND HE WAS ADMITTED IN THE INTENSIVE CARE UNIT. IT WAS STATED THAT AN MRI WAS DONE, AND HE WAS WEARING THE INSULIN PUMP. IT WAS ALSO STATED THAT THE HOSPITAL PERSONNEL FOUND THAT THE INFUSION SET WAS RIPPED OUT OFF THE CUSTOMER. THE SPOUSE STATED THAT THE INSULIN PUMP STARTED ALARMING MOTOR ERROR, AND ALL THE SETTINGS WERE ERASED OFF. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16625 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 58 YR Hospitalization