BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KR 670G MG MEDI RECERT

    MDR report key: 13832284 · Received March 20, 2022

    Report

    Report Number
    2032227-2022-162058
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    May 27, 2021
    Report Date
    April 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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). S/W 4.11E. RETAINER RING = BLACK. UNIT PASSED THE DISPLACEMENT TEST. FORMAT HISTORY FILE AND LONG TRACE FILES ANALYSIS DID NOT CONFIRMED PUMP ERROR 3, 19, 28 AND 81 ALARMS. NO UNEXPECTED PUMP ERROR'S 3,19,28 AND 81 ALARMS NOTED DURING TESTING. HOWEVER, FORMAT HISTORY FILE ANALYSIS CONFIRMED PUMP ERROR 63 (VARIABLE 9) DUE TO SOFTWARE ERROR. THE UNIT P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. UNIT PASSED THE DISPLACEMENT TEST. FORMAT HISTORY FILE AND LONG TRACE FILES ANALYSIS DID NOT CONFIRMED PUMP ERROR 3, 19, 28 AND 81 ALARMS. NO UNEXPECTED PUMP ERROR'S 3,19,28 AND 81 ALARMS NOTED DURING TESTING. HOWEVER, FORMAT HISTORY FILE ANALYSIS CONFIRMED PUMP ERROR 63 (VARIABLE OE) DUE TO HARDWARE ERROR. THE UNIT P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY. NO PHYSICAL DAMAGE NOTED DURING VISUAL INSPECTION. PUMP ERROR 63 ALARM VARIABLE (0E) WAS CONFIRMED, PROBLEM ISOLATED TO ELECTRONICS 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 81, PUMP ERROR 63, PUMP ERROR 28, PUMP ERROR 19, 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
    989172 PUMP MMT-1780KR 670G MG MEDI RECERT ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KR HG4Z9YB 000000763000365912

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Unknown