BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DES

    MDR report key: 12527027 · Received September 24, 2021

    Report

    Report Number
    2032227-2021-198020
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    September 20, 2021
    Report Date
    February 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169400986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, CUSTOMER ALLEGED THE INSULIN PUMP HAVING KEYPAD/ BUTTON UNRESPONSIVE. DEVICE HAD UNRESPONSIVE DOWN AND ACT BUTTONS DUE TO UNLOCKED LIQUID CRYSTAL DISPLAY KEYPAD CONNECTOR. UNABLE TO PERFORM SELF-TEST, AND DISPLACEMENT TEST DUE TO UNRESPONSIVE BUTTON. RECONNECTED LIQUID CRYSTAL DISPLAY KEYPAD CONNECTOR. INSULIN 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 INSULIN PUMP NOT HAVING POWER FOR A LONG PERIOD OF TIME. INSULIN PUMP WAS CUT AND OPEN FOUND NO MOISTURE/DAMAGE ON THE ELECTRONICS, BATTERY CONNECTOR, BATTERY TUBE, MOTOR, VIBRATOR, KEYPAD FLEX TAIL, KEYPAD TRACE NOTED DURING VISUAL INSPECTION. DEVICE HAD CRACKED LIQUID CRYSTAL DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED CASE AT DISPLAY WINDOW CORNERS, STAINED ADDRESS/SERIAL NUMBER LABEL AND STAINED END CAP STICKER. THE TEST RESERVOIR LOCKED IN PLACE PROPERLY AND NO ANOMALY NOTED. IN CONCLUSION, UNRESPONSIVE DOWN AND ACT BUTTONS DUE TO UNLOCKED LIQUID CRYSTAL DISPLAY KEYPAD CONNECTOR 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 · 1

    (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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A DOWN ARROW THAT WAS NOT RESPONDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427879 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DES PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754DES A7754DESJ 000000643169400986

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown