BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920029 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86486
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO FLUSH/LOOSE DRIVE SUPPORT DISK. NO PRIME ALARMS WERE NOTED. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, MISSING END CAP STICKER AND BROKEN BELT CLIP SLOT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP WAS ALARMING DURING THE PRIMING PROCESS. CUSTOMER STATED THAT INSULIN HAD BEEN SQUIRTING OUT DURING MANUAL PRIMING. ADVISED CUSTOMER TO DISCONNECT FROM THE DEVICE AND DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE DRIVE SUPPORT CAP WAS PROTRUDING FROM THE INSULIN PUMP. CUSTOMER STATED THEY HAD NOTICED THE PROTRUDING DRIVE SUPPORT CAP EARLIER AND HAD ATTEMPTED TO PUSH IT BACK IN. INFORMED CUSTOMER THE DEVICE WAS ALARMING DUE TO AN INABILITY TO DETECT THE RESERVOIR. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO HEALTHCARE PROVIDER'S INSTRUCTIONS. CUSTOMER DID NOT PROVIDE BLOOD GLUCOSE LEVELS AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397039 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR