BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945040 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-87774
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ANOMALY DURING THE REWIND/ FILL TUBING PROCESS OF THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 233 MG/DL. THE CUSTOMER STATED THAT THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THEY WERE HOLDING DOWN THE BUTTON TO FILL THE TUBING, AND THEN ONCE THE BUTTON WAS RELEASED THE DEVICE COUNTED THE DROPS OF INSULIN BUT DID NOT PROCEED TO THE NEXT STEP. ASSISTANCE WAS PROVIDED AND THE CUSTOMER STATED THAT THEY WERE STILL HAVING TROUBLE. INSULIN DID EXIT THROUGH THE TUBING HOWEVER THE NUMBERS DID NOT APPEAR ON THE SCREEN OF THE DEVICE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421476 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR