BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 8100644 · Received November 26, 2018

    Report

    Report Number
    2032227-2018-66080
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 14, 2018
    Report Date
    May 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169999763
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A BROKEN RESERVOIR TUBE LIP, MISSING RETAINER AND MISSING RESERVOIR TUBE O-RING. THE TEST RESERVOIR DOES NOT LOCK IN PLACE AND UNABLE TO PERFORM THE DISPLACEMENT TEST AND OCCLUSION TEST DUE TO THE MISSING RETAINER AND BROKEN RESERVOIR TUBE LIP. THE PUMP PASSED THE REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND SELF TEST. NO UNEXPECTED AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR ALARM NOTED DURING TESTING. HOWEVER, MOISTURE DAMAGE IN THE RESERVOIR TUBE AND MOTOR ASSEMBLY AND A CORRODED MOTOR HOME SWITCH NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE WAS 5.4 MMOL/L. THE CUSTOMER REPORTS THERE WAS A CRACK IN PLASTIC AT BATTERY SIDE ALSO THE RETENTION RING WHERE THERE WAS A PIECE OF PLASTIC MISSING. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR. CUSTOMER STATED THAT THE PUMP ERROR DID NOT OCCUR DURING THE REWIND AND LOAD RESERVOIR AND FILL TUBING PROCESS. CUSTOMER ALSO STATED THE SELF TEST AND DISPLACEMENT TEST WAS OK. THE DEVISE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941022 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG2470N 00643169999763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown