BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP MMT-511WWB

    MDR report key: 13926281 · Received March 28, 2022

    Report

    Report Number
    2032227-2022-172335
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    May 6, 2008
    Report Date
    March 28, 2022
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SV 2.0A. ON MAY 06, 2008 CUSTOMER RETURNED PUMP FOR AN ALLEGED E21 ALARM DURING BATTERY CHANGE CAN NOT BE CLEAR. UNIT RECEIVED WITH CONSTANT A21 ALARM AFTER BATTERY CHANGE AND RESETS TIME/DATE TO FACTORY DEFAULT. UNABLE TO PERFORM A21 ERROR TEST AND DISPLACEMENT TEST DUE TO C13 VOLTAGE LEAK AT INTERFACE BOARD. HOWEVER, MOISTURE DAMAGE AT ELECTRONIC ASSEMBLY. ALSO, MOISTURE DAMAGE MOTOR DURING VISUAL INSPECTION. PERFORM BRUSH CLEANING WITH THE ISOPROPYL ALCOHOL AND CLEANING UP ALL CORROSION ON ALL THE PCBA AND POWERED STILL HAVING SAME ISSUED. THE ORIGINAL M/B BOARD AND RF BOARD WAS REMOVED AND REPLACE WITH A TEST MOTHER AND RF BOARD. NO ANOMALIES WERE NOTICE AFTER BATTERY INSERT. PROBLEM ISOLATED TO M/B AND RF BOARDS. 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 PUMP NOT HAVING POWER FOR A LONG PERIOD OF TIME. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP. THE TEST P-CAP/RESERVOIR DOES LOCK INTO PLACE. THE ORIGINAL M/B AND I/F BOARD WERE REMOVED CONDUCTING INTENSIVE TROUBLESHOOTING ON THE I/F BOARD DISCOVERED C13 VOLTAGE LEAK FORM THE CAP MEASURING FAILED . HOWEVER, USING THE TEST M/B AND I/F BOARD NO ANOMALIES WERE NOTICE AFTER BATTERY INSERT. PROBLEM ISOLATED TO I/F BOARD. 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 HAD UNEXPECTED RESTART. CUSTOMER WAS NOT ABLE TO SUCCESSFULLY CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393569 PARADIGM INSULIN INFUSION PUMP MMT-511WWB PUMP, INFUSION, INSULIN LZG MEDTRONIC MINIMED MMT-511WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown