BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12551972 · Received September 30, 2021

    Report

    Report Number
    2032227-2021-199787
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 27, 2021
    Report Date
    February 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, AN UNSPECIFIED ALARM ,MOISTURE DAMAGE AND COSMETIC DAMAGE LOCATED AT THE BATTERY COMPARTMENT FOUND ON (B)(6) 2021. DEVICE WAS RECEIVED WITH A BLANK DISPLAY. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST, SELF TEST OR VERIFY CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM DUE TO BLANK DISPLAY. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1 AND THE FORCE SENSOR. SWAPPED OUT PCBA1 FOR TEST BOARD, CONFIRMED BLANK DISPLAY DUE TO MOISTURE DAMAGE DON THE PCBA 1. A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS OBSERVED AFTER UTILIZATION OF TEST PCBA 1. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.8 MV). CRITICAL PUMP ERROR ALARM DUE TO MOISTURE DAMAGE TO THE FORCE SENSOR AS PER GLOBAL LOGIC ANALYSIS. UNABLE TO FIND SPECIFIED ALARM ON THE EVENT DATE IN THE HISTORY FILE OR TRACES. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING OVERLAY, CRACKED BATTERY TUBE, SCRATCHED CASE AND MOISTURE DAMAGE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO PUMP ERROR 53. BLANK DISPLAY DUE TO MOISTURE DAMAGE ON PCBA 1. PUMP ERROR 53 ALARM DUE TO MOISTURE DAMAGE ON THE FORCE SENSOR. CRACKED BATTERY TUBE CONFIRMED DURING VISUAL INSPECTION. UNABLE TO CONFIRM UNSPECIFIED ALARM. 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 A CRITICAL PUMP ERROR ALARM AND OTHER PUMP ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. INSULIN PUMP HAD CRACK AT BATTERY COMPARTMENT. 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
    1448994 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 HG59DQUZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female