BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 17697420 · Received September 7, 2023

    Report

    Report Number
    2032227-2023-268769
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 24, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000578640
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. AFTER MULTIPLE BATTERY REPLACEMENT UNIT PERSISTED ON BLANK DISPLAY. PUMP RECEIVED WITH BLANK DISPLAY DUE TO CRACKED CASE BEHIND THE PUMP AT THE BATTERY COMPARTMENT CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. THE BATTERY TUBE ASSEMBLY WAS PUSH BACK IN THE RIGHT POSITION, MONITORED AND NO BLANK DISPLAY NOTED. UNIT WAS DOWNLOADED SUCCESSFULLY USING (THUMP SOFTWARE) FOR REFERENCE. PROCEED IT WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. PUMP PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, SELF TEST AND DISPLACEMENT TEST. NO BLANK DISPLAY, LOW BATTERY ALARMS OR UNEXPECTED BATTERY POWER LOSS NOTED DURING TESTING. THE POWER MANAGEMENT GRAPH IS WITHIN SPEC. UNIT ALSO RECEIVED WITH CRACKED CASE (BATTERY TUBE), CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP RAILS AND SCRATCH CASE. IN CONCLUSION, UNIT WAS RECEIVED WITH A BLANK DISPLAY DUE TO CRACKED CASE IN MULTIPLE LOCATIONS CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. AFTER POSITIONING THE BATTERY TUBE IN PLACE UNIT POWERED BACK ON AND THE TESTING OF THE UNIT WAS SUCCESSFUL. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED INSULIN PUMP HAD A CRACK ALONG BATTERY COMPARTMENT. THE CUSTOMER ALSO REPORTED OF RECEIVING A POWER LOSS ALARM, TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ABLE TO CLEAR THE ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293654 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3296678H 000000763000578640

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male