BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 17265533 · Received July 6, 2023

    Report

    Report Number
    2032227-2023-232305
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 18, 2023
    Report Date
    August 22, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO PUMP ERROR 130 ALARM NOTED DURING TESTING. HOWEVER, PUMP ERROR 130 WAS CONFIRMED ON 06/16/2023 AT 18:07:10.000, ON 06/17/2023 AT 17:17:17.000, ON 06/17/2023 1AT 7:20:35.000, 06/18/2023 14:57:37.000, AND ON 06/16/2023 AT 18:07:10.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, OR FORCE SENSOR. MOISTURE DAMAGE WAS FOUND ON THE MOTOR. PUMP ERROR 130 WAS CONFIRMED DUE TO MOISTURE DAMAGE ON THE MOTOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, FADED END CAP ADDRESS LABEL, SCRATCHED KEYPAD OVERLAY AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 18-JUN-2023 IN THE PUMP HISTORY FILE. 06/16/2023 18:07:10.000 ALARMALERTNOTIFICATION, FAULTNUMBER = MFDA ALARM(130). 06/16/2023 18:18:34.000 BATTERYREMOVED. 06/16/2023 18:18:34.000 ALARMALERTNOTIFICATION, FAULTNUMBER = BATTERY REMOVED (84). 06/16/2023 18:18:44.000 BATTERYINSERTED. 06/16/2023 18:19:28.000 BATTERYREMOVED. 06/16/2023 18:19:28.000 ALARMALERTNOTIFICATION, FAULTNUMBER = BATTERY REMOVED (84). 06/16/2023 18:19:58.000 BATTERYINSERTED. 06/17/2023 17:17:17.000 ALARMALERTNOTIFICATION, FAULTNUMBER = MFDA ALARM(130). 06/17/2023 17:20:35.000 ALARMALERTNOTIFICATION, FAULTNUMBER = MFDA ALARM(130). 06/18/2023 14:57:37.000 ALARMALERTNOTIFICATION, FAULTNUMBER = MFDA ALARM(130). PUMP ERROR 130 CONFIRMED IN THE PUMP HISTORY. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 17-JUN-2023 IN THE PUMP HISTORY FILE. 06/16/2023 18:07:10.000 ALARMALERTNOTIFICATION, FAULTNUMBER = MFDA ALARM(130). 06/16/2023 18:18:34.000 BATTERYREMOVED. 06/16/2023 18:18:34.000 ALARMALERTNOTIFICATION, FAULTNUMBER = BATTERY REMOVED (84). 06/16/2023 18:18:44.000 BATTERYINSERTED. 06/16/2023 18:19:28.000 BATTERYREMOVED. 06/16/2023 18:19:28.000 ALARMALERTNOTIFICATION, FAULTNUMBER = BATTERY REMOVED (84). 06/16/2023 18:19:58.000 BATTERYINSERTED. 06/17/2023 17:17:17.000 ALARMALERTNOTIFICATION, FAULTNUMBER = MFDA ALARM(130). 06/17/2023 17:20:35.000 ALARMALERTNOTIFICATION, FAULTNUMBER = MFDA ALARM(130). PUMP ERROR 130 CONFIRMED IN THE PUMP HISTORY. THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. PUMP ERROR 130 WAS CONFIRMED IN THE PUMP HISTORY FILE. 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. 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

    UPDATED DESCRIPTION: THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED A (PUMP ERROR 130) THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT. TROUBLESHOOTING WAS PERFORMED AND WAS ABLE CLEAR THE ALARM AND THE PUMP GOT REWIND. ADVISED THE CUSTOMER TO DO A DISPLACEMENT TEST ON THE PUMP AND IT GOT PASSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE USING THE INSULIN PUMP AND THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885586 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG54725

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female