BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711H

    MDR report key: 14998917 · Received July 13, 2022

    Report

    Report Number
    2032227-2022-283479
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    November 26, 2016
    Report Date
    July 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER.RECALL: Z-0958-2020.(B)(4).THIS RECORD WAS CONVERTED. FOR ADDITIONAL INFORMATION ABOUT THE ANALYSIS, PLEASE SEE SAP.UNIT PASSED REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCESENSOR TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT ANDSELFTEST. UNIT RECEIVED WITH MISSING RETAINER. UNABLE TO PERFORMDISPLACEMENT TEST AND OCCLUSION TEST DUE TO MISSING RETAINER. NOUNEXPECTED LOW BATTERY ALERTS NOTED DURING TESTING OR IN THE FORMATHISTORY FILE. PUMP ERROR 25 WAS PRESENT IN THE FORMAT HISTORY FILE ANDPUMP ERROR 25 WAS TRIGGERED WHEN THE LITHIUM BACKUP BATTERY (LOADEDVLITH) WAS LESS THAN 3.50V FOR 240 CONSECUTIVE MINUTES AS INDICATED INTHE POWER MANAGEMENT GRAPH DUE TO CONNECTOR RESISTANCE ISSUE (J6).CONNECTOR FOR J6 ON PCBA 1 WAS PROPERLY CONNECTED DURING VISUALINSPECTION. THE J6 CONNECTOR WAS DISCONNECTED AND RECONNECTED THENMONITORED FOR 2 DAYS WITH THE UNIT FUNCTIONING PROPERLY DURING TESTINGAS SHOWN IN THE POWER MANAGEMENT GRAPH. UNIT RECEIVED WITH MISSINGRESERVOIR TUBE O-RING, SCRATCHED CASING, MINOR SCRATCHES ON LCD WINDOW,PILLOWING KEYPAD OVERLAY AND DAMAGED KEYPAD OVERLAY TEMEDTRONIC, 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

    THIS COMPLAINT IS PART OF THE RETROSPECTIVE REVIEW AND REMEDIATION PER (B)(4), CLASS I AND II FIELD CORRECTIVE ACTION MDR REMEDIATION PLAN FOR DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059734 640G INSULIN PUMP MMT-1711H PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown