BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 16853390 · Received May 2, 2023

    Report

    Report Number
    2032227-2023-201405
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 18, 2023
    Report Date
    June 15, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000578640
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    S/W VERSION 5.3 A RETAINER RING = BLACK CASE TYPE = NGP CUSTOMER RETURNED PUMP FOR ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) FOUND ON (B)(6) 2023. PUMP IMMEDIATELY ALARMED AN OPEN BOOK IMAGE ONCE INSTALLING AN AA LITHIUM BATTERY. UNABLE TO PERFORM DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE). TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO THE RESERVOIR COMPARTMENT. SUCCESSFULLY UTILIZED THUMP SOFTWARE TO DOWNLOAD HISTORY FILES AND TRACES. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED AND WAS TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 3 CRITICAL HANDLING ALARMS (FILE NUMBER: 2002, LINE NUMBER: 1541, ESF# : 3923533) ON THE EVENT DATE OF (B)(6) 2023 AT 01:52:12.000, AND 02:00:02.000. IN TRACES THERE ARE LOGGED TWO OCCURRENCES OF ISSUE. AFTER THE FIRST OCCURRENCE TWO NEXT FOLLOWED SHORTLY AFTER RESTART. THIRD OCCURRENCE IS NOT LOGGED IN TRACES. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND FORCE SENSOR. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, AND CORRODED BATTERY TUBE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) WAS CONFIRMED DURING TESTING DUE TO THREE CONSECUTIVE PUMP ERROR 3 ALARMS. PUMP ERROR 3 ALARM WAS CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. MOISTURE DAMAGE WAS CONFIRMED FOUND ON THE ELECTRONIC ASSEMBLY, AND FORCE SENSOR. 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 CUSTOMER RECEIVED A CRITICAL PUMP ERROR ON THE INSULIN PUMP SCREEN. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE CUSTOMER RECEIVED AN OPEN BOOK IMAGE ALARM AND WAS SLEEPING WHEN THE ALARM OCCURRED. IT WAS REPORTED THAT THE INSULIN PUMP PERFORMED SAFETY CHECKS, AND AN ERROR WAS FOUND, BUT THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE, AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800178 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3275003H 000000763000578640

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female