BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16804859 · Received April 25, 2023

    Report

    Report Number
    2032227-2023-195316
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 11, 2023
    Report Date
    July 19, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000423131
    PMA / PMN Number
    P150019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO RESETS TIME/DATE TO FACTORY DEFAULT AFTER BATTERY CHANGE. UNIT PASSED OPERATING CURRENTS, SELF-TEST, A21 ERROR TEST, DISPLACEMENT TEST REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED REWIND ANOMALY, MOTOR LOUD NOISE ANOMALY, LOW BATTERY, NO DELIVERY ALARMS NOTED DURING TESTING. PUMP HISTORY DOWNLOAD USING THDS WAS SUCCESSFUL. HOWEVER, A47 ALARMS FOUND ON THE HISTORY FILE WHICH CAUSED CORRUPTED DATA. UNABLE TO CONFIRM THE REPORTED EVENT DATE DUE TO THE CORRUPTED DATA. A47 ALARMS ARE DUE TO THE PUMP NOT HAVING POWER FOR A LONG PERIOD OF TIME. PUMP WAS CUT AND OPEN FOUND NO MOISTURE/DAMAGE ON THE ELECTRONICS, BATTERY CONNECTOR, MOTOR, VIBRATOR, KEYPAD FLEX TAIL, KEYPAD TRACE NOTED DURING VISUAL INSPECTION. MOTOR PASSED MOTOR TEST. UNIT HAD CRACKED BATTERY TUBE THREADS, STAINED ADDRESS/SERIAL NUMBER LABEL AND STAINED END CAP STICKER. THE TEST RESERVOIR LOCKED IN PLACE PROPERLY AND NO ANOMALY NOTED. IN CONCLUSION, PUMP HAVING RESETS TIME/DATE TO FACTORY DEFAULT AFTER BATTERY CHANGE, REWIND ANOMALY, MOTOR LOUD NOISE ANOMALY, LOW BATTERY, NO DELIVERY ALARMS NOT CONFIRMED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    (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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER LOST PUMP SETTINGS WHEN CHANGING THE BATTERIES AND FOUND IT SLOWER TO REWIND AND MADE A LOT OF NOISE AND GRINDING SOUND DURING THE PUMP REWIND. THE CUSTOMER ALSO HAD NO DELIVERY ALARMS AND NO ALARM DURING THE LOW BATTERY. NO ADDITIONAL DETAILS WERE PROVIDED. TROUBLESHOOTING COULD NOT BE PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163408 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 A8723LNASJ 000000763000423131

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female