BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS

    MDR report key: 9317271 · Received November 13, 2019

    Report

    Report Number
    2032227-2019-116822
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    November 4, 2019
    Report Date
    January 24, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000161132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME OR A33 TEST, EXCESSIVE NO DELIVERY TEST , OCCLUSION TEST AND SELF TEST. NO A45 ERROR FOUND IN HISTORY FILE. NO MOISTURE NOTED IN THE RESERVOIR TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED SHE NOTICED INSULIN INSIDE THE RESERVOIR COMPARTMENT SO SHE CLEANED IT WITH A (B)(6). CUSTOMER WAS REPORTING A PAST EVENT AND STATED SHE DID THIS STEP LAST NIGHT AND STATED LEAK WAS NOT OCCURRING FROM RESERVOIR BARREL OR O RINGS. CUSTOMER REPORTS O-RING INSIDE LIP OF RESERVOIR COMPARTMENT WAS NOT MISSING. CUSTOMER REPORTED SELF TEST FAILED AND PUMP SHUT OFF AFTER TEST WAS COMPLETE. CUSTOMER STATED SHE RECEIVED AN ALARM. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARMS. CUSTOMER WAS ABLE TO COMPLETE REWIND BUT THE DISPLACEMENT TEST FAILED AND PUMP SHUT OFF AFTER THE SELF TEST WAS COMPLETE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113322 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS A7723LNASJ 00763000161132

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR