BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 13735548 · Received March 11, 2022

    Report

    Report Number
    2032227-2022-124298
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    August 25, 2021
    Report Date
    June 9, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. (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.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER COMPLAINED ABOUT THE DEVICE HAVING PUMP ERROR 54, PUMP ERROR 53 AND PUMP ERROR 3 ON EVENT DATE OF AUG 25, 2021. DEVICE PASSED DISPLACEMENT TEST AND P-CAP/RESERVOIR DOES LOCK PROPERLY. PUMP FAILED SELF TEST DURING TESTING. HISTORY/TRACE DOWNLOADS WERE SUCCESSFUL USING THUS SOFTWARE. PUMP ERROR 54 (FILE NUMBER = 32122, LINE NUMBER = 1421), ESF#: ESF3010978, WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF 08/25/2021 09:38:43.000 DUE TO POSSIBLE SOFTWARE ISSUE. PUMP ERROR 53 (FILE NUMBER = 2005, LINE NUMBER = 5632), ESF#: ESF2610666, WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF 08/25/2021 09:39:28.000 DUE TO POSSIBLE SOFTWARE DEFECT. PUMP ERROR 3 CONFIRMED ON 08/25/2021 09:38:45.000 IN CONSEQUENCE OF PUMP ERROR 54. PUMP ERROR 63 VAR 03 ALARMED DURING TESTING ON 04/26/2022 07:52:32.000 DUE TO A BROKEN TRACE. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. NO MOISTURE DAMAGE NOTED ON PCB1/PCB2 NOTED UPON VISUAL INSPECTION OF COMPONENTS. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, SCRATCHED CASE AND DAMAGED DISPLAY WINDOW COVER. PUMP ERROR 53 CONFIRMED DUE TO SOFTWARE DEFECT. PUMP ERROR 54 AND PUMP ERROR 3 BOTH CONFIRMED DUE TO SOFTWARE ISSUES. PUMP TRACE DOWNLOAD CONFIRMED THE PUMP ALARMED PUMP ERROR 63 VARIABLE 03 DUE TO BROKEN TRACE U1 PIN6 ON KEYPAD ASSEMBLY. 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

    MEDTRONIC RECEIVED INFORMATION THAT PUMP ERROR 53, PUMP ERROR 54, PUMP ERROR 3 OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792318 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG3XFRU 000000763000283544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown