BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 11691571 · Received April 20, 2021

    Report

    Report Number
    2032227-2021-136843
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    April 15, 2021
    Report Date
    January 19, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. ON APR 15, 2021 THE CUSTOMER ALLEGED THEY RECEIVED A CRITICAL PUMP ERROR (OPEN BOOK) ALARM AND WAS HOSPITALIZED, BUT HOSPITALIZATION WAS UNRELATED TO THE PRODUCT. DEVICE RECEIVED WITH CRITICAL PUMP ERROR (OPEN BOOK) ALARM. THUMP SOFTWARE WAS UTILIZED TO DOWNLOAD HISTORY FILES AND TRACES SUCCESSFULLY. FOUND INTERNAL FLASH CRC (55) [MAR 20, 2021 15:58] IN THE INSULIN PUMP DIAGNOSTIC TRACE AS PER GLOBAL LOGIC ANALYSIS. UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT ACCURACY TEST AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK). DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS ASSEMBLY, 40 PIN FLEXIBLE PRINTED CIRCUIT/LCD, INTERNAL BATTERY, MOTOR ASSEMBLY, BATTERY TUBE ASSEMBLY, KEYPAD ASSEMBLY AND VIBRATOR. IN CONCLUSION, INSULIN PUMP RECEIVED WITH CRITICAL PUMP ERROR (OPEN BOOK) AND FOUND INTERNAL FLASH CRC (PUMP ERROR 55 ALARM) IN THE INSULIN PUMP DIAGNOSTIC TRACE SUSPECTED TO BE IN THE PCB 2. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. NO DAMAGE ON THE RETAINER DURING VISUAL INSPECTION. DEVICE RECEIVED WITH PILLOWING KEYPAD OVERLAY. HOSPITALIZATION UNRELATED TO THE PRODUCT. CRITICAL PUMP ERROR (OPEN BOOK) ALARM CONFIRMED AND TRIGGERED BY PUMP ERROR 55 ALARM. PUMP ERROR 55 ALARM CONFIRMED DUE TO A HARDWARE ERROR. 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

    RETAINER RING = BLACK. DEVICE RECEIVED WITH CRITICAL PUMP ERROR (OPEN BOOK) AND THUMP SOFTWARE WAS UTILIZED AND SUCCESSFUL. FOUND INTERNAL FLASH CRC IN THE PUMP DIAGNOSTIC TRACE. UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT ACCURACY TEST AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK). DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS ASSEMBLY, 40 PIN FLEXIBLE PRINTED CIRCUIT/LCD, INTERNAL BATTERY, MOTOR ASSEMBLY, BATTERY TUBE ASSEMBLY, KEYPAD ASSEMBLY AND VIBRATOR. IN CONCLUSION, PUMP RECEIVED WITH CRITICAL PUMP ERROR (OPEN BOOK) AND FOUND INTERNAL FLASH CRC (PUMP ERROR 55 ALARM) IN THE PUMP DIAGNOSTIC TRACE SUSPECTED TO BE IN THE ELECTRICAL BOARD 2. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. NO DAMAGE ON THE RETAINER DURING VISUAL INSPECTION. DEVICE RECEIVED WITH PILLOWING KEYPAD OVERLAY. 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

    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. THE INFORMATION HAS BEEN UPDATED AND PROVIDED IN B5 SECTION OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY WERE HOSPITALIZED FOR A NON-DIABETIC AND NON-MEDTRONIC PRODUCT REASON. WHEN HE RETURNED HOME, HE WAS ATTEMPTING TO RECONNECT TO THE INSULIN PUMP AND WAS RECEIVING AN OPEN BOOK IMAGE. INSULIN PUMP ERROR ALARM WAS NOT DISPLAYED BEFORE THE OPEN BOOK IMAGE WAS DISPLAYED ON THE SCREEN. CUSTOMER DECLINED TO PROVIDE BLOOD GLUCOSE VALUE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 749 MG/DL AT TIME OF INCIDENT. CUSTOMER WAS TRIED TO USE THE INSULIN PUMP BUT IT WAS SHOWING THE OPEN BOOK IMAGE. INSULIN PUMP ERROR ALARM WAS NOT DISPLAYED BEFORE THE OPEN BOOK IMAGE WAS DISPLAYED ON THE SCREEN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590808 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 HG4VQM9ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization FRN-UNK-RSVR, UNOMED INF SET.| FRN-UNK-RSVR, UNOMED INF SET.