BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 15453722 · Received September 20, 2022

    Report

    Report Number
    2032227-2022-340508
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    November 18, 2020
    Report Date
    September 20, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETAINER = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED NO COMMUNICATION (UNRESOLVED) FOUND ON (B)(6) 2020. INSULIN PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF-TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY MULTIPLE PUMP ERROR 53 CRITICAL HANDLING ALARMS (B)(6) 2020 06:23:32, (B)(6) 2020 06:23:54, (B)(6) 2020 06:24:25, (B)(6) 2020 06:25:16. INSULIN PUMP ERROR 53 ALARM DUE TO SOFTWARE ERROR ((B)(4)). PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. FORCE SENSOR ZERO OFFSET IS WITHIN SPECIFICATION 23.6MV. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: UNABLE TO VERIFY NO COMMUNICATION (UNRESOLVED) DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO THREE CONSECUTIVE PUMP ERROR 53 ALARMS. PUMP ERROR 53 ALARM DUE TO SOFTWARE ERROR ((B)(4)) ESF# (B)(4). THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640 INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER WANT TO RETURN THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694631 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