BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12531627 · Received September 27, 2021

    Report

    Report Number
    2032227-2021-198256
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 23, 2021
    Report Date
    March 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER RETURNED PUMP FOR ALLEGED PUMP ERROR 53, PUMP ERROR 3, AND LABEL ANOMALY FOUND ON (B)(6) 2021. UNIT PASSED DISPLACEMENT TEST AND SELF TEST. NO PUMP ERROR 53 OR PUMP ERROR 3 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOAD TO THUS. THE PUMP HISTORY DOWNLOAD CONFIRMED PUMP ERROR 54 (FILE NUMBER (B)(4) LINE NUMBER (B)(4)) DUE TO SOFTWARE ERROR AND PUMP ERROR 3 ON (B)(6) 2021 AT 02:57:36.000. PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS (ESF#3010978). PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND NO MOISTURE OR PHYSICAL DAMAGE WAS FOUND ON PCBA 1, PCBA 2 OR THE MOTOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, MISSING DISPLAY WINDOW COVER, CRACKED CORNER OF BELT CLIP RAILS, CRACKED BATTERY TUBE THREADS, FADED SERIAL LABEL DAMAGE, CRACKED RETAINER, CRACKED RESERVOIR TUBE LIP, MISSING END CAP ADDRESS LABEL, AND MINOR SCRATCHES ON LCD WINDOW. IN SUMMARY, CUSTOMER ALLEGATION FOR PUMP ERROR 53 WAS NOT CONFIRMED; HOWEVER, PUMP ERROR 54 AND PUMP ERROR 3 WAS CONFIRMED IN PUMP DOWNLOADED HISTORY. LABEL ANOMALY WAS CONFIRMED DURING VISUAL INSPECTION WHERE FADED SERIAL LABEL DAMAGE AND MISSING END CAP ADDRESS LABEL WAS NOTED. 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 · 0

    (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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARMS. 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
    1435924 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG387V7 000000763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown