BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS

    MDR report key: 13519926 · Received February 13, 2022

    Report

    Report Number
    2032227-2022-112516
    Event Type
    Malfunction
    Date Received
    February 13, 2022
    Date of Event
    January 26, 2022
    Report Date
    April 29, 2022
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    UDI-DI
    000000613994409553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ON JAN 26, 2021 THE CUSTOMER RETURNED PUMP FOR AN ALLEGED MOTOR ERROR ALARM. DEVICE RECEIVED WITH MOTOR ERROR DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. 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. A33 CONFIRMED WAS SHOWN ON DOWN LOAD REPORT WAS ON 01/26/21 17:51:14 ALARM # 43 AT LINE 3422 IN SOURCE FILE # 24 HEX = 06 2B 0D 5E 0E 73 71 1A 15 . THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: BROKEN BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP. DEVICE WAS RECEIVED WITH 15% OF RESERVOIR TUBE LIP BROKEN OFF, HOWEVER THE TEST INFUSION SET AND RESERVOIR DID LOCK PROPERLY INTO PLACE. THE ORIGINAL MOTOR WAS REMOVED AND REPLACE WITH A TEST MOTOR. NO ANOMALIES WAS NOTICE. PROBLEM ISOLATED THE MOTOR. 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 INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS ACTING UP DUE TO A MOTOR ERROR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784199 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAS PARADIGM REAL TIME REVEL PUMP OYC MEDTRONIC MINIMED MMT-722LNAS A000114695 000000613994409553

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female