BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12524680 · Received September 24, 2021

    Report

    Report Number
    2032227-2021-197760
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    September 22, 2021
    Report Date
    March 2, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK ON (B)(6) 2021 THE CUSTOMER REPORTED PUMP ERRORS 37 AND 43. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. DID NOT NOTE ANY CRACKS IN OR AROUND THE RESERVOIR TUBE LIP, OR IN THE RETAINER RING. FURTHERMORE, THE RETAINER RING IS SOLIDLY ATTACHED TO THE RESERVOIR TUBE LIP. IN ADDITION TO THIS, DID NOT NOTE ANY CRACKS IN THE BATTERY TUBE OR IN THE BATTERY THREADS. DEVICE PASSED SELF TEST; IT FAILED REWIND TEST. DURING MOTOR REWIND, THE UNIT RETURNED A PUMP ERROR 38. UNABLE TO PERFORM THE DISPLACEMENT, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, AND OCCLUSION TESTS DUE TO THE RECURRING PUMP ERROR 38. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE ADAPT TOOL CONFIRMS THAT A PUMP ERROR 37 OCCURRED ON (B)(6) 202113:31, 13:33, AND 13:59 AND PUMP ERROR 43 OCCURRED ON (B)(6) 2021 @ 09:16, 13:32, AND 13:36. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, THERE IS RUST ON THE HOME MOTOR SWITCH, AND THE RUBBER STOPPER OF THE MOTOR SLIDE IS MISSING. IN SUMMARY, THE CUSTOMER¿S REPORT OF A PUMP ERRORS 37 AND 43 WERE NOT CONFIRMED. THE PUMP ERROR 38 IS DUE TO RUST ON THE HOME MOTOR SWITCH. 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 PUMP ERROR ALARMS. CUSTOMER REPORTED INSULIN PUMP WAS NOT WORKING AND ASKING TO LOAD RESERVOIR. CUSTOMER PERFORMED DISPLACEMENT TEST BUT FAILED. CUSTOMER STATED INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC ENVIRONMENT. THE TROUBLE SHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS OBSERVED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427661 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4GGE4 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female