BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER

    MDR report key: 12437531 · Received September 8, 2021

    Report

    Report Number
    2032227-2021-190168
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 31, 2021
    Report Date
    February 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000258436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR ON (B)(6) 2021 THE CUSTOMER REPORTED A "POWER FAILURE" ALARM. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. DID NOT NOTE ANY CRACKS IN OR AROUND THE RESERVOIR TUBE LIP, OR IN THE RETAINER RING. FURTHERMORE, THE RETAINER RING IS SOLIDLY ATTACHED TO THE RESERVOIR TUBE LIP. IN ADDITION TO THIS, DID NOT NOTE ANY CRACKS IN THE BATTERY TUBE OR IN THE BATTERY THREADS. UNIT PASSED DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS. NO UNEXPECTED ¿LOW BATTERY¿, ¿REPLACE BATTERY¿, "INSERT BATTERY", ¿BATTERY FAILED¿ ERRORS WERE NOTED DURING TESTING; HOWEVER, MULTIPLE PUMP ERROR 25 = "POWER LOSS" ERRORS DID OCCUR DURING TESTING. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE ADAPT TOOL CONFIRMS PUMP ERROR 25 AT THE FOLLOWING TIMES: 6 ALARMS ON (B)(6) 2021; (B)(6) 2021 @ 1:00 AND 1:10; (B)(6) 2021 @ 6:57 AND 10:57. THE ADAPT TOOL CONFIRMS MULTIPLE OCCURRENCES OF THE FOLLOWING ALERTS/ALARMS AROUND THE EVENT DATE: 104=LOW BATTERY--OCCURRING @ (B)(6) 2021 12:12, (B)(6) 2021 20:19, (B)(6) 2021 01:56 TO NAME A FEW. THIS ALERT IS WITHIN THE EXPECTED INTERVAL OF 2 WEEKS OF EACH OTHER. THE ADAPT TOOL DID NOT LIST ANY UNUSUAL PUMP ERRORS OTHER THAN THE PUMP ERROR 25. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, DID NOT NOTE ANY SIGNS OF PREVIOUS MOISTURE PRESENCE OR CORROSION ON ANY OF THE BOARDS, ASSEMBLIES, AND THE MOTOR INSIDE THE UNIT. THE INTERNAL BATTERY ESR MEASUREMENT TEST WAS USED TO TEST THE INTERNAL BATTERY, AND IT FAILED. NO TRACE OF THE INTERNAL BATTERY APPEARED ON THE OSCILLOSCOPE WHATSOEVER. IN SUMMARY, THE CUSTOMER¿S REPORT OF A "POWER FAILURE" ALARM WAS CONFIRMED DURING TESTING. THE PUMP ERROR 25 = "POWER FAILURE" ALARM IS DUE TO A BAD INTERNAL BATTERY. (B)(4). 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR AND INSULIN PUMP FAILURE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341262 PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1741KX A000637231 000000763000258436

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown