BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS

    MDR report key: 16154946 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-108794
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    March 9, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000161279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SW 3.1E. ON (B)(6) 2022 CUSTOMER ALLEGED THE PUMP HAVING MOTOR ERROR ALARM, RESET TIME/DATE AFTER A BATTERY CHANGE. UNIT PASSED SELF TEST, A21 ERROR TEST, REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED MOTOR ERROR ALARM OR RESET ALARM NOTED DURING TESTING. PUMP HISTORY DOWNLOAD USING THDS WAS SUCCESSFUL. THERE IS NO MOTOR ERROR, RESET ALARMS ON EVENT DATE 09-MAR-2022. PUMP WAS CUT AND OPEN FOUND NO MOISTURE/DAMAGE ON THE ELECTRONICS, BATTERY CONNECTOR, BATTERY TUBE, MOTOR, VIBRATOR, KEYPAD FLEX TAIL NOTED DURING VISUAL INSPECTION. MOTOR PASSED MOTOR TEST. THE TEST RESERVOIR LOCKED IN PLACE PROPERLY AND NO ANOMALY NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: STAINED ADDRESS/SERIAL NUMBER LABEL. UNIT PASSED ALL REQUIRED TEST. MOTOR ERROR ALARM AND RESET TIME/DATE AFTER A BATTERY CHANGE 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT REPROGRAM ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064941 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 Unknown