BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 16194496 · Received January 18, 2023

    Report

    Report Number
    2032227-2023-127989
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 29, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CASE TYPE = NGP. ON 01/09/2023 THE CUSTOMER REPORTED UNRESPONSIVE KEYPAD BUTTONS AND EXPOSURE TO WATER. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE RETAINER RING IS SOLIDLY ATTACHED TO THE RESERVOIR TUBE LIP. DID NOT NOTE ANY CRACKS IN OR AROUND THE RESERVOIR TUBE LIP, OR IN THE RETAINER RING. DID NOT NOTE ANY CRACKS IN THE BATTERY TUBE OR IN THE BATTERY THREADS. UNIT PASSED DISPLACEMENT TEST; IT FAILED SELF TEST. NO STUCK BUTTONS, MULTIPLE PRESS ISSUES, BUTTON RESPONSE DELAYS, OR OTHER KEYPAD ANOMALIES WERE NOTED DURING TESTING. ALL BUTTONS WERE TESTED WHILE NAVIGATING THE MENUS, AND THEY ALL WORKED PROPERLY. SELF TEST FAILED BECAUSE THE VIBRATOR FAILED TO VIBRATE WHEN IT WAS SUPPOSED TO. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE ADAPT TOOL DOES NOT LIST ANY 61=STUCK KEY ALARMS AROUND THE EVENT DATE NOR DOES IT LIST ANY PUMP ERRORS THAT COULD POTENTIALLY TRIGGER A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) WHATSOEVER. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, THERE IS CORROSION IN/AROUND THE FOLLOWING: PCBA1--J7, DA2. IN ADDITION TO THIS, THE VIBRATOR IS UNABLE TO VIBRATE SINCE THE WIRE LEADING TO IT ON THE BATTERY BOARD WAS CUT. THE UNIT PASSED THE KEYPAD VOLTAGE TEST. IN SUMMARY, THE CUSTOMER¿S REPORT OF UNRESPONSIVE KEYPAD BUTTONS WAS NOT CONFIRMED BUT THAT OF EXPOSURE TO WATER WAS CONFIRMED DURING TESTING. THE UNIT DOES NOT MEET SPEC DUE TO THE CUT WIRE AND THE MOISTURE DAMAGE. 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

    (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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 780G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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 THE PUMP WAS EXPOSED TO MOISTURE AND SOME KEYPADS WERE UNRESPONSIVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND IT WAS FOUND THAT THE BOLUS WAS NOT DONE BECAUSE THE MIDDLE KEYPAD WAS UNRESPONSIVE. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE, WHICH WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4757 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG62C6J 000000763000521509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown