BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12223133 · Received July 25, 2021

    Report

    Report Number
    2032227-2021-171692
    Event Type
    Injury
    Date Received
    July 25, 2021
    Date of Event
    July 14, 2021
    Report Date
    March 8, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169513914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 CUSTOMER ALLEGED THE PUMP MOTOR ERROR ALARM. DEVICE HAD UNRESPONSIVE BUTTONS DUE TO FLATTENED (CREASED) ESC AND ACT BUTTONS DOME SWITCH. NO UNLOCKED J2/LCD KEYPAD CONNECTOR NOTED. UNABLE TO PERFORM REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST OR VERIFY MOTOR ERROR ALARM DUE TO UNRESPONSIVE BUTTONS. DEVICE 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. DEVICE 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. DEVICE HAD CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, STAINED ADDRESS/SERIAL NUMBER LABEL, STAINED END CAP STICKER. THE TEST RESERVOIR LOCKED IN PLACE PROPERLY AND NO ANOMALY NOTED. IN CONCLUSION, UNABLE TO CONFIRM MOTOR ERROR ALARM DUE TO BUTTON KEYPAD ANOMALY. UNRESPONSIVE BUTTONS DUE TO FLATTENED (CREASED) ESC AND ACT BUTTONS DOME SWITCH WAS CONFIRMED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THE INSULIN PUMP HAD SOME ISSUES WITH THE MOTOR. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ABLE TO CLEAR AND REWIND THE PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120124 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 A5723LNASJ 000000643169513914

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other FRN-MMT-332A,UNOMED-MMT-397| FRN-MMT-332A,UNOMED-MMT-397