BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3990328 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91280
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR WINDOW. THE DEVICE PASSED THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. NO SCROLLING NUMBERS NOTED DURING TESTING. ALL BUTTONS FUNCTION PROPERLY. HOWEVER MOISTURE DAMAGE WAS NOTED ON KEYPAD TRACES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BUTTONS ARE STUCK AND NOT RESPONDING AND CUSTOMER STATED THE INSULIN PUMP MIGHT HAVE A DELIVERY ANOMALY. CUSTOMER WAS INSTRUCTED THAT SHE HAD A SCROLLING ISSUE AND INSULIN DELIVERY WAS NOT AFFECTED. BLOOD GLUCOSE LEVEL IS 197 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463391 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR