BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 12472706 · Received September 15, 2021

    Report

    Report Number
    2032227-2021-192618
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 28, 2021
    Report Date
    January 7, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 CUSTOMER REPORTS THAT HE/SHE RECEIVED REPLACE BATTERY ALERTS OVER AND OVER AGAIN. 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. DEVICE PASSED DISPLACEMENT, SLEEP CURRENT MEASUREMENT, AND ACTIVE CURRENT MEASUREMENT TESTS. NO UNEXPECTED LOW BATTERY, REPLACE BATTERY, INSERT BATTERY, BATTERY FAILED, OR POWER LOSS ERRORS WERE NOTED DURING TESTING. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. NO PUMP ERROR 25 WAS NOTED DURING TESTING, IN THE DEVICE HISTORY FILE, IN THE LONG TRACE FILE, OR IN THE POWER MANAGEMENT GRAPH. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY UNUSUAL BATTERY ALARMS OR INSULIN PUMP ERRORS THAT MAY HAVE OCCURRED AROUND THE EVENT DATE. THE ADAPT TOOL CONFIRMS THAT THE CUSTOMER RECEIVED MULTIPLE 104=LOW BATTERY ALERTS ON (B)(6) 2021 AT 11:00, 14:09, 22:42 TO NAME A FEW AND THAT HE/SHE RECEIVED MULTIPLE 73=CHANGE BATTERY FAULTS ON (B)(6) 2021 AT 20:14, 20:24, AND ON (B)(6) 2021 AT 16:06 TO NAME A FEW ALL OF THESE OCCURRED LESS THAN THE EXPECTED INTERVAL OF 2 WEEKS OF EACH OTHER. DID NOT NOTE ANY UNUSUAL INSULIN PUMP ERRORS THAT HAVE OCCURRED AROUND THE EVENT DATE. 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 DEVICE. IN SUMMARY, CUSTOMER REPORT OF RECEIVING REPLACE BATTERY ALERTS OVER AND OVER AGAIN WAS NOT CONFIRMED DURING TESTING. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. 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 · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REPLACE BATTERY ALERT. CUSTOMER STATED THAT THE INSULIN PUMP GAVE LOW BATTERY ALERT PRIOR TO REPLACE BATTERY ALERT. CUSTOMER STATED THAT THE NEW BATTERY DID NOT RESOLVED THE ISSUE. CUSTOMER STATED THAT THE INSULIN PUMP WAS PASSED IN SELF TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375730 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG4QBTW 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male