BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12371907 · Received August 26, 2021

    Report

    Report Number
    2032227-2021-185384
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    August 13, 2021
    Report Date
    March 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 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 DELIVERY ACCURACY TEST. THUS AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. ALL BUTTONS FUNCTIONING PROPERLY. NO STUCK BUTTON ALARM DURING TESTING OR IN THE DEVICE HISTORY NOTED. THE KEYPAD OVERLAY WAS PEELED OFF, REMOVE THE KEYPAD DOME SWITCHES TO PERFORM THE KEYPAD TEST AND PASSED. NO MOISTURE OR COMPONENT DAMAGE ON THE KEYPAD TRACES OR KEYPAD DOMES DURING THE VISUAL INSPECTION. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR, MOTOR ASSEMBLY, KEYPAD FLEX TAIL AND THE KEYPAD CONNECTOR ON ELECTRICAL BOARD 1 WAS LOCKED PROPERLY. THE FORCE SENSOR OFFSET MEASURED WITHIN SPECIFIC RANGE DURING TESTING (25.3 MILIVOLTS). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NEXT GENERATION INSULIN PUMP STB3 AND PASSED. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. NO DAMAGE ON THE RETAINER DURING VISUAL INSPECTION. DEVICE RECEIVED WITH PILLOWING KEYPAD OVERLAY. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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

    RETAINER RING = BLACK. ON (B)(6) 2021 THE CUSTOMER ALLEGED PUMP RECEIVING STUCK ERROR ALARMS AND WAS HOSPITALIZED FOR HIGH BGS. 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 0.08690 INCHES. THUS AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. ALL BUTTONS FUNCTIONING PROPERLY. NO STUCK BUTTON ALARM DURING TESTING OR IN THE PUMP HISTORY NOTED. THE KEYPAD OVERLAY WAS PEELED OFF, REMOVE THE KEYPAD DOME SWITCHES TO PERFORM THE KEYPAD TEST AND PASSED. NO MOISTURE OR COMPONENT DAMAGE ON THE KEYPAD TRACES OR KEYPAD DOMES DURING THE VISUAL INSPECTION. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR, MOTOR ASSEMBLY, KEYPAD FLEX TAIL AND THE KEYPAD CONNECTOR ON J1/PCB 1 WAS LOCKED PROPERLY. THE FORCE SENSOR OFFSET MEASURED WITHIN SPEC RANGE DURING TESTING (25.3 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. NO DAMAGE ON THE RETAINER DURING VISUAL INSPECTION. PUMP RECEIVED WITH PILLOWING KEYPAD OVERLAY. IN SUMMARY, CUSTOMER ALLEGATION FOR PUMP RECEIVING STUCK BUTTON ALARM NOT CONFIRMED DURING FULL FUNCTIONAL TESTING OR IN THE PUMP HISTORY/TRACE FILES. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON AUGUST 18, 2021. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP STARTED UP BUT BUTTONS WERE NOT REACTING. CUSTOMER HAS DOWN SYNDROME AND HAS ASSISTANCE TO TAKE CARE OF THEM. AUTO MODE FEATURE INFORMATION WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270723 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG3QTKR 000000763000264727

    Patients

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