BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 16289732 · Received February 3, 2023

    Report

    Report Number
    2032227-2023-140978
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 18, 2023
    Report Date
    March 3, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT RECEIVED PUMP ERROR 43 ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION TESTS, AND SELF TESTS OR VERIFY ERROR 130 ALARM DUE TO THE PUMP ERROR 130. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW IN THE PUMP HISTORY FOUND MULTIPLE 130 ALARMS ON 01/18/2023 09:31:41, 01/18/2023 09:32:18, 01/18/2023 09:41:44.000, 01/18/2023 09:33:00, 01/18/2023 09:35:56, 01/18/2023 09:51:08 AND PUMP ERROR 43 ALARM ON 01/18/2023 09:48:21, 01/18/2023 09:50:41, 01/18/2023 12:11:14, 01/18/2023 12:21:00. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA1/PCBA2, MOTOR, SENSOR CABLE DURING VISUAL INSPECTION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: UNIT HAD SCRATCHED CASE, KEYPAD OVERLAY TEXTURE DAMAGE, CRACKED BATTERY TUBE THREADS, CRACKED CASE (BATTERY TUBE), LABEL DAMAGE. IN CONCLUSION, PUMP ERROR 43 DURING REWIND AND PUMP ERROR 130, 43 ALARMS IN THE PUMP HISTORY CONFIRMED DUE TO CORRODED MOTOR HOME SWITCH. PUMP CRACKED CASE (BATTERY TUBE) AND MOISTURE DAMAGE CONFIRMED. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 CUSTOMER RECEIVED PUMP ERROR 43 WITH  130 , CRACK ON BACK OF THE PUMP AND STATED THE PUMP WAS EXPOSED TO MOISTURE . NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS UNABLE TO REWIND THE PUMP .IT UNABLE TO  CLEARED THE ALARMS, CUSTOMER WILL DISCONTINUE TO USE THE DEVICE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384586 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5JH9C 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female