BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781KL 670G MG RPL

    MDR report key: 16081978 · Received January 2, 2023

    Report

    Report Number
    2032227-2023-100431
    Event Type
    Malfunction
    Date Received
    January 2, 2023
    Date of Event
    December 23, 2022
    Report Date
    March 20, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK . CASE TYPE NGP. THE PUMP WAS RETURNED FOR CHARGE BATTERY ALARM ON EVENT DATE (B)(6) 2022. UNIT PASSED THE DISPLACEMENT TEST AND SELF-TEST. SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITHIN SPECIFICATIONS. THE HISTORY WAS DOWNLOAD SUCCESSFULLY USING THUS SOFTWARE. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. DETAILED TRACE ANALYSIS DID NOT CONFIRM PUMP ERROR 25 ALARM WAS TRIGGERED. BACKUP BATTERY UNLOADED OR LOADED VOLTAGE (UL VLITH) DID NOT DROP BELOW 3.5V FOR CONSECUTIVE 240 MINUTES. NO UNEXPECTED BATTERY ALARMS NOTED ON LONG TRACE HISTORY FILES RELATED TO EVENT DATE. HOWEVER, PUMP ERROR 3 AND 54 NOTED ON LONG HISTORY FILE ON (B)(6) 2022 17:48:55:000 PM AND 12/10 2022 17:48:53:000 PM DUE TO MOISTURE DAMAGE. UNIT WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE NOTED ON FORCE SENSOR, 40 PIN FLEXIBLE PRINTED CIRCUIT/LCD, ELECTRONICS STACK PCBA1, PCBA2, MOTOR AND BATTERY TUBE. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS, CRACKED BATTERY TUBE THREADS AND CRACKED CASE AT BATTERY TUBE SIDE. THE UNIT P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY. UNIT WAS NOT CONFIRMED FOR PUMP ERROR 25 ALARM ANOMALIES. HOWEVER, PUMP ERROR 3 AND 54 NOTED ON LONG HISTORY FILE ON 12/10/2022 17:48:55:000 PM AND 12/10 2022 17:48:53:000 PM DUE TO MOISTURE DAMAGE. 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 · 0

    (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. 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 MULTIPLE PUMP ERROR ALARMS AND POWER ERROR ALARM DETECTED FOR 4 TIMES. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564114 PUMP MMT-1781KL 670G MG RPL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781KL HG4RC6T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown