BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12293862 · Received August 9, 2021

    Report

    Report Number
    2032227-2021-178178
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 30, 2021
    Report Date
    October 24, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/30/2021 CUSTOMER ALLEGED PUMP FOR ALARMING CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AFTER THE INSULIN PUMP WAS SUBMERGED IN WATER FOR 5 MINS. DEVICE HISTORY AND TRACE FILES WILL BE DOWNLOADED USING THUMP SOFTWARE IN ORDER TO VERIFY ANY FATAL OR REOCCURRING INSULIN PUMP ERRORS THAT TRIGGERED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. THE FOLLOWING TESTS WILL BE PERFORMED: DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. DEVICE WILL BE CUT OPEN AND INSPECTED FOR ANY DAMAGE ON THE ELECTRONIC ASSEMBLIES. P-CAP / RESERVOIR LOCKS PROPERLY INTO PLACE. DEVICE RECEIVED WITH A FROZEN DISPLAY WITH FLASHING MEDTRONIC LOGO. RESET THE INSULIN PUMP THREE TIMES TO DETERMINE FLASHING MEDTRONIC LOGO IS PERMANENT. FROZEN DISPLAY OCCURRED DUE TO SEVERE MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLIES. UNABLE TO DOWNLOAD DEVICE'S HISTORY AND TRACE FILES USING THUMP SOFTWARE DUE TO FROZEN SCREEN ANOMALY CAUSED FOR SEVERE MOISTURE DAMAGE AT THE ELECTRONIC ASSEMBLIES. DEVICE UNABLE TO PERFORM DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST OR VERIFY CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM DUE TO FROZEN DISPLAY ANOMALY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED CASE, CRACKED CASE NEAR THE CORNER OF BELT CLIP RAILS, CRACKED BATTERY TUBE THREADS, AND CRACKED CASE ON THE BATTERY TUBE SIDE. 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 AN OPEN BOOK IMAGE ON SCREEN AFTER BEING EXPOSED TO MOISTURE. THE SCREEN WAS ALL BLACK NOW AND ONLY THE RED LIGHT WAS FLASHING. THE INSULIN PUMP DID NOT PASS SELF TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191628 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG4U21SZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR