BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781KL 670G MG RPL

    MDR report key: 16370412 · Received February 14, 2023

    Report

    Report Number
    2032227-2023-158699
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 31, 2023
    Report Date
    June 10, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    S/W VERSION 4.11J. RETAINER RING = BLACK. CASE TYPE = NGP. CUSTOMER RETURNED PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON 31-JAN-2023. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. THE PUMP PASSED THE DISPLACEMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, AND SELF TEST. PUMP FAILED ACTIVE CURRENT MEASUREMENT DUE TO HIGH CURRENT READING, PROBLEM ISOLATED TO MOISTURE DAMAGE ON THE LCD FLEX CONNECTOR (PCBA 1). PUMP FAILED SLEEP CURRENT MEASUREMENT DUE TO HIGH CURRENT READING, PROBLEM ISOLATED TO MOISTURE DAMAGE ON THE LCD FLEX CONNECTOR (PCBA 1). SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO UNEXPECTED ALARMS NOTED DURING TESTING; HOWEVER, VERIFIED THE PUMP ALARMED PUMP ERROR 53 (FILE NUMBER = 0 AND LINE NUMBER = 0 AND ESF #: 1925624) ON 01/31/2023 AT TIME 17:27:01.000 DUE TO HARDWARE ANOMALY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, AND FORCE SENSOR. NO FATAL CRITICAL ALARMS OR THREE CONSECUTIVE CRITICAL HANDLING ALARMS FOUND IN THE HISTORY FILES OR TRACES. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: BATTERY TUBE THREADS - CRACKED, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, AND PILLOWING KEYPAD OVERLAY. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS NOT OBSERVED DURING TESTING. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOT CONFIRMED. PUMP ERROR 53 WAS CONFIRMED IN THE HISTORY FILES DUE TO HARDWARE ANOMALY. UNEXPECTED BATTERY POWER LOSS WAS CONFIRMED DUE TO HIGH SLEEP CURRENT AND HIGH ACTIVE CURRENT. HIGH CURRENTS ISOLATED TO MOISTURE DAMAGE ON THE LCD FLEX CONNECTOR (PCBA 1). PUMP EXPOSED TO MOISTURE CONFIRMED ON THE PCBA 1, PCBA 2, AND FORCE SENSOR. *EDIT SUMMARY. FAILED CURRENT TESTS* 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 CUSTOMER RECEIVED A CRITICAL PUMP ERROR ON THE INSULIN PUMP SCREEN. THE CUSTOMER RECEIVED AN OPEN BOOK IMAGE ALARM. IT WAS REPORTED THAT THE INSULIN PUMP PERFORMED SAFETY CHECKS AND THE ERROR WAS FOUND. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655140 PUMP MMT-1781KL 670G MG RPL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781KL NG3200166H 000000763000283568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown