BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 14509371 · Received May 26, 2022

    Report

    Report Number
    2032227-2022-195201
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 16, 2022
    Report Date
    October 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08755 INCHES. HOWEVER, PUMP HAD UNEXPECTED PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68, PUMP ERROR 25 AFTER MONITORING FOR SEVERAL MINUTES, PUMP ERROR 75 ALARM DURING SELF TEST AND HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. THE PUMP TRACE DOWNLOAD ANALYSIS CONFIRMED THE PUMP ALARMED PUMP ERROR 25, PUMP ERROR 75 ALARM, PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM. PUMP ERROR 68 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/16/2022 16:18:28.000 TO 05/16/2022 16:19:45.000. 05/16/2022 21:46:40.000. PUMP ERROR 49 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/16/2022 16:18:2 TO 05/16/2022 16:20:33.000. 05/16/2022 21:46:40.000 AND 05/16/2022 21:47:15.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/16/2022 16:19:18.000 TO 05/16/2022 16:19:18.000. PUMP ERROR 75 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/16/2022 21:45:27.000 TO 05/16/2022 22:50:35.000. PUMP ERROR 25 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/17/2022 02:00:00.000 TO 05/17/2022 02:00:00.000. 05/17/2022 06:00:00.000 TO 05/17/2022 06:49:00.000. THE POWER MANAGEMENT TOOL CONFIRMED PUMP ERROR 25 ALARM, PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM, PUMP ERROR 23 ALARM, PUMP ERROR 75 ALARM DURING SELF TEST AND HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) DUE TO CONNECTOR RESISTANCE (J6 PCB 1). AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON J6 PCBA 1, PUMP WAS MONITORED AND FUNCTIONED PROPERLY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68, PUMP ERROR 25, PUMP ERROR 75 ALARM DURING SELF TEST AND HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WERE CONFIRMED. PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68, PUMP ERROR 25, PUMP ERROR 75 ALARM DURING SELF TEST AND HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WERE DUE TO CONNECTOR RESISTANCE (J6 PCB 1). 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 INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM SUCCESSFULLY. CUSTOMER REPORTED THAT THEY WERE UNABLE TO REWIND PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386804 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG5MRL1 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female