BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 15902990 · Received December 2, 2022

    Report

    Report Number
    2032227-2022-368988
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 9, 2022
    Report Date
    April 6, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP RECEIVED WITH ALL BUTTONS FUNCTIONING PROPERLY. PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, AND SELF-TEST. THUS WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW IN THE PUMP MEMORY/HISTORY FOUND MULTIPLE: PUMP ERROR 4 (ESF# = N/A, FILE NUMBER = 32010, AND LINE NUMBER = 2773) ON THE EVENT DATE OF (B)(6) 2022 09:59:17.000 TO (B)(6) 2022 11:10:52.000. PUMP ERROR 42 ON THE EVENT DATE OF 11/09/2022 09:59:19.000. PUMP ERROR 53 ((B)(4)) ON THE EVENT DATE OF (B)(6) 2022 09:57:43.000 TO (B)(6) 2022 10:48:41.000. PUMP ERROR 53 ((B)(4)) ON THE EVENT DATE OF (B)(6) 2022 09:57:43.000 TO (B)(6) 2022 10:48:41.000. PUMP ERROR 54 (ESF# = N/A, FILE NUMBER = 32010, AND LINE NUMBER = 1616) ON THE EVENT DATE OF (B)(6) 2022 10:04:48.000 TO (B)(6) 2022 11:17:06.000. PUMP ERROR 61 ON THE EVENT DATE OF (B)(6) 2022 08:52:23.000 TO (B)(6) 2022 11:50:41.000. PUMP ERROR 63 (VARIABLE = 3, FILE NUMBER = 37, AND LINE NUMBER = 367) ON THE EVENT DATE OF (B)(6) 2022 10:21:26.000. NO PUMP ERROR 4/42/53/54/61/63 ALARM DURING TESTING. NO STUCK KEY ALARMS NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, AND MOTOR. THE MOTOR WAS NOT TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 DUE TO MOISTURE DAMAGE ON THE MOTOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: BATTERY TUBE THREADS - CRACKED, SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED CASE-CORNER OF BELT CLIP RAILS, AND PILLOWING KEYPAD OVERLAY. PUMP ERROR 42 WAS CONFIRMED DUE TO MOISTURE DAMAGE ON MOTOR. PUMP ERROR 4/54 WAS CONFIRMED DUE TO HARDWARE ANOMALY, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY. STUCK BUTTON ALARM WAS NOT CONFIRMED DURING TESTING. PUMP ERROR 63 WAS CONFIRMED DUE TO BROKEN SOLDER AT PIN 6 AND PIN 1 OF THE U1 CHIP ON KEYPAD ASSEMBLY. PUMP ERROR 53 WAS CONFIRMED, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY. MOISTURE DAMAGE WAS CONFIRMED ON THE PCBA 1, PCBA 2, FORCE SENSOR, AND MOTOR. 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 THE CUSTOMER REPORTED THAT THE PUMP HAS A STUCK BUTTON ERROR ALARM. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT ALARM OCCURRED MORE THAN THREE MINUTES. INSULIN PUMP WAS RESET BUT SAME ERROR RETURNED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797450 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG6098G 000000763000283537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown