BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12267013 · Received August 3, 2021

    Report

    Report Number
    2032227-2021-175725
    Event Type
    Death
    Date Received
    August 3, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 27, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000069001
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED ANALYSIS SUMMARY BY (B)(4) ON FEB 09, 2022 : RETAINER RING = MISSING. ON MAY 11, 2021, THE INSULIN PUMP WAS RETURNED DUE TO PATIENT PASSING AWAY, BUT NOT ALLEGING DEVICE. THE DEVICE DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. DEVICE PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, OCCLUSION TEST AND DELIVERY ACCURACY TEST DUE TO MISSING RETAINER. THE TEST P-CAP AND RESERVOIR WILL NOT LOCK IN PLACE IN THE RESERVOIR COMPARTMENT DUE TO MISSING RETAINER. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. DEVICE ALSO HAD A MISSING RESERVOIR TUBE O-RING, BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT BATTERY TUBE SIDE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. DATA ANALYSIS: THE FORMATTED HISTORY FILE LISTS DATA FROM 08/31/2020 TO 04/13/2021. IN SUMMARY, INSULIN PUMP PASSED ALL REQUIRED TESTING. INSULIN PUMP WAS NOT RETURNED FOR AN ALLEGATION. UNABLE TO PERFORM THE DISPLACEMENT TEST, DISPLACEMENT ACCURACY TEST AND OCCLUSION TEST DUE TO MISSING RETAINER. 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 REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0958-2020 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

    THE UNIT DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. UNIT PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, OCCLUSION TEST AND DAT TEST DUE TO MISSING RETAINER. THE TEST P-CAP AND RESERVOIR WILL NOT LOCK IN PLACE IN THE RESERVOIR COMPARTMENT DUE TO MISSING RETAINER. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. UNIT ALSO HAD A MISSING RESERVOIR TUBE O-RING, BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT BATTERY TUBE SIDE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. DATA ANALYSIS: THE FORMATTED HISTORY FILE LISTS DATA FROM 08/31/2020 TO 04/13/2021. (B)(4). THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS UNKNOWN. THE REPORTING PARTY DID NOT STATE WHETHER THE CUSTOMER HAD ANY ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. NO OTHER INFORMATION WAS PROVIDED DUE TO PRIVACY LAWS. THE CALLER AGREED RETURN THE INSULIN PUMP FOR ANALYSIS. THIS REPORT WAS MADE SOLELY FOR THE FAILURE ANALYSIS RESULTS. FRN-UNK-RSVR UNOMED SET. THE TEST P-CAP AND RESERVOIR WILL NOT LOCK IN PLACE IN THE RESERVOIR COMPARTMENT DUE TO MISSING RETAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169150 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K 000000763000069001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown