BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 13759688 · Received March 14, 2022

    Report

    Report Number
    2032227-2022-135889
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    January 12, 2022
    Report Date
    July 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365905
    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. ON 12-JAN-2022 CUSTOMER ALLEGED PUMP RECEIVED PUMP ERROR 53, PUMP ERROR 4, ERROR 81 AND ERROR 82. THE PUMP PASSED DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF-TEST. CONFIRMED DOWNLOAD OF PUMP'S HISTORY AND TRACE FILES USING THUS. HOWEVER, THE HISTORY/TRACE DOWNLOAD CONFIRMED. PUMP ERROR 4 (LINE NUMBER 2727 FILE NUMBER 32122) ALARMS ON 01/12/2022 18:28:22. PUMP ERROR 53 (LINE NUMBER 5632 FILE NUMBER 2005) ALARMS ON 01/12/2022 18:22:53. PUMP ERROR 3 (LINE NUMBER 2803 FILE NUMBER 2002) ALARMS ON 01/12/2022 13:08:29. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND NO ALARMS NOTED DURING TESTING. P-CAP / RESERVOIR LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, SERIAL NUMBER LABEL MISSING, AND CORRODED BATTERY TUBE. PUMP ERROR 53 (LINE NUMBER 5632 FILE NUMBER 2005) ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 01/12/2022 18:22:53 DUE TO A SOFTWARE ERROR (ESF# (B)(4). PUMP ERROR 4 ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 01/12/2022 18:28:22 DUE TO SOFTWARE ERROR CONFIRMED IN PUMP ERROR 53. PUMP ERROR 3 ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 01/12/2022 13:08:29 DUE TO SOFTWARE ERROR CONFIRMED IN PUMP ERROR 53. PUMP ERROR 81 ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 01/12/2022 13:16:11 PROBLEM ISOLATED TO MOTOR. PUMP ERROR 82 ALARMS CONFIRMED IN THE PUMP HISTORY/TRACE FILES ON 01/12/2022 13:16:11 PROBLEM ISOLATED TO MOTOR. 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 3, PUMP ERROR 4, PUMP ERROR 82, PUMP ERROR 81, PUMP ERROR 53 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
    1234297 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL HG55Y1M 000000763000365905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown