BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1711KL 640G V4.10 BK SF MM

    MDR report key: 16796502 · Received April 24, 2023

    Report

    Report Number
    2032227-2023-195028
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    April 7, 2023
    Report Date
    June 23, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH A MISSING RESERVOIR TUBE O-RING AND A MISSING RETAINER. THE PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, DISPLACEMENT ACCURACY TEST AND OCCLUSION TEST DUE TO A MISSING RESERVOIR TUBE O-RING AND A MISSING RETAINER. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY DOWNLOADED COMLINK3 FILE. THERE WERE NO FATAL CRITICAL ALARMS, OR THREE CONSECUTIVE CRITICAL HANDLING ALARMS FOUND IN THE FORMATTED HISTORY FILE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS DUE TO THE RF TEST FAILURE IN THE BOOTLOADER (CODE 0X00000045). SUSPECTING HW ISSUE. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 07-APR-2023 IN THE FORMATTED HISTORY FILE.  PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (FILE NUMBER: 2005 LINE NUMBER: 9926) WERE RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 04/06/2023 19:05:52.000 AND (B)(6) 2023 19:05:53.000 PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (FILE NUMBER: 2005 LINE NUMBER: 9926), SUSPECTED ON HW. PUMP ERROR 68 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 19:05:55.000 PUMP ERROR 49 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 19:05:55.000 (B)(6) 2023 19:06:20.000 PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 19:06:31.000 PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE EXPECTED SINCE THE PUMP RESTARTED DUE TO PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM. PUMP ERROR 61 (STUCK KEY ALARM) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 10:33:15.000 (B)(6) 2023 10:33:15.000 ALL BUTTONS FUNCTION PROPERLY. NO STUCK BUTTON ALARM NOTED DURING THE TESTING. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND SLIGHT CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE MOTOR AND VIBRATOR¿ASSEMBLY NOTED. THE J1 CONNECTOR ON PCBA 1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. PUMP ERROR 61 (STUCK KEY ALARM) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON KEYPAD ASSEMBLY. UNABLE TO LOCK A TEST P-CAP INTO THE RESERVOIR COMPARTMENT DUE TO A MISSING RESERVOIR TUBE O-RING AND A MISSING RETAINER. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED CASE, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. RETAINER RING DAMAGE (A MISSING RESERVOIR TUBE O-RING AND A MISSING RETAINER) WERE CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED DUE TO SLIGHT CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (FILE NUMBER: 2005 LINE NUMBER: 9926) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. PUMP ERROR 61 (STUCK KEY ALARM) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON KEYPAD ASSEMBLY. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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/OPEN BOOK IMAGE. THE INSULIN PUMP PERFORMED SAFETY CHECKS AND THE ERROR WAS FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686169 PUMP MMT-1711KL 640G V4.10 BK SF MM PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711KL HG64YGE 000000763000317119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown