BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3760171 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-83806
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    MOISTURE DAMAGE TO THE KEYPAD TRACES OBSERVED DURING VISUAL INSPECTION. HOWEVER, THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. A SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP ALSO NOTED.

    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

    CUSTOMER REPORTED THAT HER INSULIN PUMP WAS NOT WORKING CORRECTLY. CUSTOMER STATED THAT THE INSULIN PUMP KEYPAD BUTTONS ARE NOT RESPONDING. STATES IT IS NOT DELIVERING THE INSULIN AND IT IS NOT ALARMING TO NOTIFY HER THAT THERE WAS A BLOCKAGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237121 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR