BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 16180558 · Received January 17, 2023

    Report

    Report Number
    2032227-2023-121053
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    October 18, 2022
    Report Date
    January 16, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUMP WAS RECEIVED WITH A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. PUMP WAS ALSO RECEIVED WITH A BLANK DISPLAY. UNABLE TO PERFORM THE 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 BLANK DISPLAY. UNABLE TO GENERATE POWER MANAGEMENT GRAPH DUE TO BLANK DISPLAY. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO BLANK DISPLAY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND J7 POWER CONNECTOR BECOMING LOOSE FROM PCBA 1 DUE TO CORRODED PCBA 1. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE PCBA 2, FORCE SENSOR, MOTOR ASSEMBLY, VIBRATOR ASSEMBLY AND BATTERY TUBE ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS INSTALLED AND SWAPPED OUT WITH A WORKING TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND NO BLANK DISPLAY NOTED. THE ORIGINAL PCBA 2 RE-INSTALLED AND SWAPPED OUT WITH A WORKING TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE AA 1.5V BATTERY AND CONTINUED ON HISTORY FILES/TRACES USING THUS DOWNLOAD. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS.¿ POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/18/2022 00:03:00.000 10/18/2022 10:36:45.000 TO 10/18/2022 10:52:00.000 10/18/2022 11:03:00.000 TO 10/18/2022 11:46:31.000 INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/18/2022 10:05:03.000 TO 10/18/2022 10:36:16.000 10/18/2022 11:01:54.000 TO 10/18/2022 11:47:16.000 REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/18/2022 09:34:00.000 REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/18/2022 10:05:00.000 FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/18/2022 10:05:17.000 TO 10/18/2022 10:51:17.000 10/18/2022 11:01:00.000 TO 10/18/2022 11:46:31.000 PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/18/2022 11:47:29.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/18/2022 11:48:04.000 10/18/2022 11:48:15.000 UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE EXPECTED SINCE THE BATTERY HAS LOW/NO POWER. THE CUSTOMER MAY HAVE USED A LOW/DEPLETED BATTERY. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT UNLOADED VAA VOLTAGE (BATTERY VOLTAGE) OF 1.6V. LOW BATTERY ALERT WAS UNEXPECTED SINCE THE CUSTOMER WAS USING A GOOD BATTERY. LOW BATTERY ALERT WAS CONFIRMED DUE TO CORROSION THE PCBA 1. BLANK DISPLAY WAS CONFIRMED DUE TO J7 POWER CONNECTOR BECOMING LOOSE FROM PCBA 1 DUE TO CORRODED PCBA 1. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO BLANK DISPLAY. BLANK DISPLAY WAS CONFIRMED DUE TO J7 POWER CONNECTOR BECOMING LOOSE FROM PCBA 1 DUE TO CORRODED PCBA 1. A TEST PCBA 1 WAS USED, CONTINUED ON HISTORY FILES/TRACES USING THUS DOWNLOAD AND NO BLANK DISPLAY NOTED. HOWEVER, LOW BATTERY ALERT WAS CONFIRMED DUE TO CORROSION THE PCBA 1. 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 DAMAGED. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225321 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL 000000763000283599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown