BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945233 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04619
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION. OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS. NO MOTOR ERROR ALARM WAS NOTED AND THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS AND A CRACKED RESERVOIR TUBE LIP. NO EXCESSIVE NO DELIVERY ALARM WAS NOTED.

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT REPEATED MOTOR ERROR AND NO DELIVERY ALARMS. THE REPORTED BG AT THE TIME OF THE CALL WAS 157 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND NO EXPOSURE TO HIGH MAGNETIC FIELDS WAS REPORTED. ADVISED THE PATIENT THAT THE PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422780 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR