BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13790006 · Received March 16, 2022

    Report

    Report Number
    2032227-2022-142472
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    March 12, 2022
    Report Date
    July 29, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER COMPLAINED ABOUT THE UNIT HAVING A PUMP ERROR 53 ON EVENT DATE OF 12-MAR-2022. THE PUMP PASSED THE DISPLACEMENT TEST AND SELFTEST. NO PUMP ERROR 53 ALARMS DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. PUMP ERROR 53 WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF 03/13/2022 02:00:09.000 ESF# 3961594, FILE NUMBER= 32 32143 32 32143 32,LINE NUMBER= 265 399 265 399 265. TESTED WITH A TEST P-CAP AND THE TEST P-CAP LOCKED IN PLACE PROPERLY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON PCB2. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, SERIAL NUMBER LABEL DAMAGE, MOISTURE DAMAGE. PUMP ERROR 53 WAS CONFIRMED DUE TO HARDWARE ERROR DUE TO MOISTURE DAMAGE ON PCB2 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 INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WILL DISCONTINUE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2600573 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG4L07EZZ 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown