BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 14984911 · Received July 12, 2022

    Report

    Report Number
    2032227-2022-281632
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    July 24, 2016
    Report Date
    July 12, 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. CORRECTION/REMOVAL NUMBER: Z-0958-2020. (B)(4). THIS RECORD WAS CONVERTED. FOR ADDITIONAL INFORMATION ABOUT THE ANALYSIS, PLEASE SEE SAP. UNIT PASSED THE FULL FUNCTIONAL TEST INCLUDING THE DISPLACEMENT TEST,REWIND, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITH IN SPECIFICATIONS. POWER MANAGEMENT PARAMETERS GRAPH CONFIRMED POWER ERROR ALARM 25 WAS TRIGGERED WHEN BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH)WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON J6/PCBA 1. PUMP WAS MONITORED AND FUNCTIONED PROPERLY. UNIT RECEIVED WITH CRACKED KEYPAD OVERLAY AT SELECT BUTTON, CRACKED RESERVOIR TUBE LIP, SCRATCHED CASE AND KEYPAD OVERLAY TEXTURE DAMAGE. J.A 10/20/16 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

    THIS COMPLAINT IS PART OF THE RETROSPECTIVE REVIEW AND REMEDIATION PER D00618926, CLASS I AND II FIELD CORRECTIVE ACTION MDR REMEDIATION PLAN FOR DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2817674 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown