BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 17115576 · Received June 13, 2023

    Report

    Report Number
    2032227-2023-216543
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 18, 2023
    Report Date
    September 26, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AFTER BATTERY INSTALLATION. 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 CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED FIRMWARE UTILIZING CREST AND THE TRACE, HISTORY, AND COMLINK3 FILES USING THUS. A REVIEW OF THE PUMP HISTORY FILE SHOWS A TOTAL OF NINE (9) PUMP ERROR 53 ALARMS, LISTED BELOW: 04/30/2023 22:08:15 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4). 05/16/2023 20:46:50 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4). 05/16/2023 20:47:36 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4). 05/16/2023 20:49:34 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4). 05/16/2023 20:59:06 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4).05/16/2023 20:59:28 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4). ON 5/16/2023 AT 21:15 THERE WERE THREE (3) CONSECUTIVE CRITICAL ERROR HANDLING PUMP ERROR 53 (LINENUMBER 5632 FILENUMBER (B)(4) ) ALARMS DUE TO A SOFTWARE ERROR AND ON THE THIRD INSTANCE, A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS GENERATED, LISTED BELOW: 05/16/2023 21:15:30 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4). 05/16/2023 21:15:52 FAULTNUMBER = SOFTWARE ERROR (53) LINENUMBER = 5632 FILENUMBER = (B)(4).THE"OPEN-BOOK" WAS GENERATED DUE TO 3 CRITICAL PE53S: THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, MISSING DISPLAY WINDOW COVER, CRACKED RESERVOIR TUBE LIP, AND PILLOWING KEYPAD OVERLAY. CRITICAL PUMP ERROR (OPEN BOOK) AND PUMP ERROR 53 ALARMS ARE CONFIRMED DUE TO A SOFTWARE ERROR. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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. 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 REPORTED RECEIVING A OPEN BOOK IMAGE DURING INSERTING NEW BATTERY. THE CUSTOMER ALSO INFORMED PUMP RESPONDS TO THE SAFETY NOTIFICATION FA896. NO FURTHER DETAILS GIVEN. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171355 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG3PXVN 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown