BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8622310 · Received May 18, 2019

    Report

    Report Number
    3004209178-2019-99044
    Event Type
    Injury
    Date Received
    May 18, 2019
    Date of Event
    May 15, 2019
    Report Date
    July 1, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE REWIND, BASIC OCCLUSION, PRIME AND DISPLACEMENT TEST. DEVICE RECEIVED WITH STUCK MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AND INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CUSTOMER¿S PARENTS REPORTED VIA PHONE CALL THAT HER DAUGHTER EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 463 MG/DL AT THE TIME OF INCIDENT. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM AND ABLE TO COMPLETE INSULIN PUMP REWIND. DRIVE SUPPORT CAP WAS NORMAL AND CUSTOMER DID NOT REPORT MOTOR POSITION ENCODER ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415557 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 A5723LNASJ 00643169513914

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other