BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 10243485 · Received July 8, 2020

    Report

    Report Number
    2032227-2020-142945
    Event Type
    Death
    Date Received
    July 8, 2020
    Date of Event
    March 20, 2020
    Report Date
    May 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000069001
    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

    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

    (B)(4). THE UNIT DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. UNIT PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT TEST AT 0.08735 INCHES. PUMP ERROR 63 (VARIABLE 3) ALARMED DURING SELF TEST DUE TO BROKEN TRACE AT U1 PIN 6 (SDA) ON KEYPAD ASSEMBLY. UNABLE TO VERIFY AUDIO/VIBRATE/ABSENCE OF ALARM DURING SELF TEST DUE TO PUMP ERROR 63. TOGGLED ON/OFF AND INCREASED/DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND CRACKED RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. 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 CALLER DID NOT STATE WHETHER THE CUSTOMER HAD ANY OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE REPORTING PARTY WAS UNSURE IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE REPORTING PARTY WAS UNSURE IF THE CUSTOMER WAS USING SENSORS. NO FURTHER INFORMATION WAS PROVIDED. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THIS REPORT IS BEING MADE FOR THE FAILURE ANALYSIS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708530 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG2JB26 00763000069001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown