BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15922466 · Received December 6, 2022

    Report

    Report Number
    2032227-2022-370873
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 11, 2022
    Report Date
    December 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169693937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. ON NOVEMBER 11, 2022 CUSTOMER RETURNED DEVICE FOR AN ALLEGED LOW BATTERY, NO DELIVERY, UNEXPECTED RESTART. A COLD RESET WAS PERFORMED./EXTERNAL RAM CRC ERROR ALARMS.DEVICE RECEIVED WITH ALL OPERATING CURRENTS WITHIN SPEC AND PASSED REWIND TEST, SELF-TEST, UNEXPECTED RESTART. A COLD RESET WAS PERFORMEDERROR TEST, DISPLACEMENT TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/COMPROMISED FORCE SENSOR SYSTEMTEST, EXCESSIVE NO DELIVERY TEST. NO UNEXPECTED MOTOR ERROR, UNEXPECTED RESTART. A COLD RESET WAS PERFORMED., EXTERNAL RAM CRC ERROR, LOW BATTERY ALARMS NOTED DURING TESTING. DEVICE HISTORY DOWNLOAD USING THDS WAS SUCCESSFUL. THERE ARE NO LOW BATTERY, NO DELIVERY, UNEXPECTED RESTART. A COLD RESET WAS PERFORMED./EXTERNAL RAM CRC ERROR ALARMS ON EVENT DATE NOVEMBER 11, 2022. NO MOISTURE DAMAGE FOUND ON THE ELECTRONICS, MOTOR, BATTERY TUBE AND VIBRATOR ASSEMBLY NOTED. THE TEST P-CAP/RESERVOIR DOES LOCK INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, STAINED END CAP STICKER, STAINED ADDRESS/SERIAL NUMBER LABEL AND CRACKED RESERVOIR TUBE LIP. DEVICE ASSED ALL REQUIRED TEST. NO UNEXPECTED LOW BATTERY, NO DELIVERY, UNEXPECTED RESTART. A COLD RESET WAS PERFORMED./EXTERNAL RAM CRC ERROR ALARMS NOTED DURING TESTING OR IN THE FILE HISTORY. 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. 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. 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

    THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS LOOSING BATTERY CHARGE AND THE CUSTOMER HAD TO RESET ALL THE SETTINGS. THE CUSTOMER ALSO HAD A21 (UNEXPECTED RESTART ERROR) AND A17 (EXTERNAL RAM CRC ERROR). NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE CUSTOMER WILL DISCONTINUE USING THE DEVICE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124660 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS A2723RNASJ 000000643169693937

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male