BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS

    MDR report key: 18027504 · Received October 30, 2023

    Report

    Report Number
    2032227-2023-292811
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 29, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000161279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. PUMP ALARMED MOTOR ERROR DURING REWIND. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARMS. PUMP HISTORY DOWNLOAD USING THDS WAS SUCCESSFUL. MOTOR ERROR ALARM CONFIRMED WAS SHOWN ON DOWN LOAD REPORT WAS ON " 08/02/23 20:13:01 ALARM #43 - ALRM_MOTOR_ERROR - MOTOR ERROR - THE GEARBOX IS STUCK, NEED TO REWIND AT LINE 6779 IN SOURCE FILE SHARED. HEX = 06 2B 1A 7B 81 0D 74 02 17. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, STAINED END CAP STICKER, STAINED ADDRESS/SERIAL NUMBER LABEL AND CRACKED RESERVOIR TUBE LIP. THE TEST P-CAP/RESERVOIR DOES LOCK INTO PLACE. UNIT RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. 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 REPORTED A MOTOR ERROR ALARM 6 TIMES. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM, THE PUMP REWIND AND IT WAS UNKNOWN WHETHER THE SELF-TEST HAD PASSED. THE CUSTOMER DID NOT REPORT THE E70 ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131247 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LWWS 000000763000161279

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Unknown