BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11781868 · Received May 6, 2021

    Report

    Report Number
    2032227-2021-142696
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    May 3, 2021
    Report Date
    August 9, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169446472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 CUSTOMER RETURNED DEVICE FOR AN ALLEGED AA33 ALARM. DEVICE ALARMED A33 DURING THE BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST DUE TO A33 ALARM. HOWEVER, DEVICE PASSED REWIND TEST AND DISPLACEMENT TEST. 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. NO MOISTURE DAMAGE FOUND ON THE ELECTRONICS, MOTOR, BATTERY TUBE AND VIBRATOR ASSEMBLY NOTED. THE TEST P-CAP/RESERVOIR DOES LOCK INTO PLACE. UNIT HAD CRACKED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, STAINED ADDRESS/SERIAL NUMBER LABEL AND STAINED END CAP STICKER. AA33 ALARM DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL AND TRIED TO CHANGE AND RESET THE PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681261 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS B3723NASJ 000000643169446472

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other FRN-MMT-332-RSVR, UNOMED SET| FRN-MMT-332-RSVR, UNOMED SET