BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 16511327 · Received March 9, 2023

    Report

    Report Number
    2032227-2023-168295
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 11, 2023
    Report Date
    April 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT, UNABLE TO CONFIRM BATTERY CAP BROKEN/CRACKED/DAMAGED DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. A TEST BATTERY CAP LOCKS SECURELY INTO PLACE AND THE PUMP POWERED UP PROPERLY. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08660 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BATTERY ANOMALIES NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 11-FEB-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 11-FEB-2023 LISTED ON SMART-SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED = 29 DAILY TOTAL OF BASAL INSULIN DELIVERED = 15.7 DAILY TOTAL OF BOLUS INSULIN DELIVERED = 13.3 02/16/2023 13:30:32.000 NORMAL BOLUS DELIVERED NORMAL BOLUS AMOUNT PROGRAMMED = 0.5 BOLUS AMOUNT DELIVERED = 0.5 02/16/2023 14:15:42.000 NORMAL BOLUS DELIVERED NORMAL BOLUS AMOUNT PROGRAMMED = 1.15 BOLUS AMOUNT DELIVERED = 1.15 02/16/2023 14:31:30.000 NORMAL BOLUS DELIVERED NORMAL BOLUS AMOUNT PROGRAMMED = 5 BOLUS AMOUNT DELIVERED = 5 02/16/2023 14:57:22.000 NORMAL BOLUS DELIVERED NORMAL BOLUS AMOUNT PROGRAMMED = 1.65 BOLUS AMOUNT DELIVERED = 1.65 02/16/2023 15:19:58.000 NORMAL BOLUS DELIVERED NORMAL BOLUS AMOUNT PROGRAMMED = 1.65 BOLUS AMOUNT DELIVERED = 1.65 02/16/2023 15:53:48.000 NORMAL BOLUS DELIVERED NORMAL BOLUS AMOUNT PROGRAMMED = 1.65 BOLUS AMOUNT DELIVERED = 1.65 02/16/2023 16:29:58.000 NORMAL BOLUS DELIVERED NORMAL BOLUS AMOUNT PROGRAMMED = 1.65 BOLUS AMOUNT DELIVERED = 1.65 THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 11-FEB-2023 IN THE FORMATTED HISTORY FILE.  NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/07/2023 21:59:02.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/01/2023 09:42:00.000 INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/01/2023 09:43:05.000 POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE 11-FEB-2023. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 14-FEB-2023 AT 9:32:54 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 01-FEB-2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/05/2023 03:07:00.000 02/05/2023 03:17:00.000 LOST SENSOR 2 ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/05/2023 03:34:00.000 SENSOR SIGNAL NOT FOUND ALERT (796) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/05/2023 04:11:00.000 THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THE PUMP WAS PROGRAMMED WITH CONTOUR NEXT TEST GLUCOSE METER. THE PUMP CONNECTED SUCCESSFULLY TO THE TEST METER AND DISPLAYED ¿BG METER CONNECTION SUCCESSFUL¿. THE PUMP WAS PROGRAMMED WITH CONTOUR NEXT TEST GLUCOSE METER. THE PUMP COMMUNICATED PROPERLY AND RECORDED THE 114 MG/DL TEST VALUE PROPERLY FROM GLUCOSE METER. THE PUMP SENSOR FEATURE IS WORKING PROPERLY. NO UNEXPECTED BG METER COMMUNICATION ERRORS OR ANOMALIES NOTED DURING TESTING. NO SENSOR GLUCOSE/BLOOD GLUCOSE (SG/BG) ANOMALY NOTED. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 12/07/2022 TO 02/21/2023. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERRORS/ALARMS 1 WEEK PRIOR TO THE EVENT DATE 11-OCT-2022 IN THE FORMATTED HISTORY FILE.  THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR¿ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.6 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RETAINER AND A CRACKED RESERVOIR TUBE LIP WERE NOTED DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS AND A SCRATCHED CASE. UNABLE TO CONFIRM BATTERY CAP BROKEN/CRACKED/DAMAGED DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. BATTERY CAP BROKEN/CRACKED/DAMAGED WAS UNKNOWN. A CRACKED RETAINER AND A CRACKED RESERVOIR TUBE LIP WERE CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS NOT CONFIRMED. SENSOR GLUCOSE/BLOOD GLUCOSE (SG/BG) ANOMALY AND BATTERY ANOMALIES WERE NOT 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 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. 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 GLUCOSE VALUE MISMATCHED AND POSSIBLE UNDER DELIVERY AND EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 20 MMOL/L AT THE TIME OF THE EVENT. THE CUSTOMER WAS TREATED WITH THE IV INSULIN DRIP, MEDICATIONS AND  ANTIBIOTICS  AND  EXPERIENCED SYMPTOMS, DIABETIC KETOACIDOSIS, NAUSEA, VOMITING, DEHYDRATED, INSTABILITY, AND SHAKING. CUSTOMER WAS HOSPITALIZED FOR 3 DAYS DUE TO THIS EVENT. TROUBLESHOOTING WAS PERFORMED AND WHETHER THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS WAS UNKNOWN. IT WAS FOUND THAT THE AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707318 PUMP MMT-1782K 670G V4.11 MM AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG383HL 000000763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H FRN-UNK-RSVR, UNOMED INF SET