BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 16145935 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-105798
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 3, 2023
    Report Date
    March 20, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CASE TYPE = NGP. THE PUMP WAS RETURNED FOR DEVICE TEST FAILED, POSSIBLE UNDER DELIVERY ANOMALY AND HIGH BG FOUND ON JAN 03, 2023. THE PUMP WAS RECEIVED WITH BATTERY CAP CONTACT MISSING. PUMP PASSED DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, ACTIVE CURRENT MEASUREMENT, SELF-TEST AND DAT AT 0.0866 INCHES. HOWEVER, UNIT RECEIVED WITH HIGH SLEEP CURRENT. POSSIBLE UNDER DELIVERY ANOMALY WAS NOT FOUND DURING TESTING OR IN THE PUMP HISTORY. PUMP¿S HISTORY AND TRACE FILES DOWNLOADED SUCCESSFULLY USING THUS SOFTWARE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. SWAPPED INTERNAL BATTERY WITH A TEST INTERNAL BATTERY AND SLEEP CURRENT MEASUREMENT TEST PASSED. TESTED THE INTERNAL BATTERY ON THE NPG SYSTEM BOARD TEST, THE INTERNAL BATTERY DID NOT PASS. THE ESR VALUE OF THE INTERNAL BATTERY WAS 4.7 OHMS. THE INTERNAL BATTERY DID MET SPEC. TEST P-CAP / RESERVOIR LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, BATTERY TUBE THREADS - CRACKED, CRACKED CASE-CORNER OF BELT CLIP RAILS AND PEELING SERIAL NUMBER LABEL. DEVICE TEST FAILED AND POSSIBLE UNDER DELIVERY ANOMALY WERE NOT CONFIRMED. UNEXPECTED BATTERY POWER LOSS WAS CONFIRMED DUE TO INTERNAL BATTERY HAVING HIGH ESR. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. BATTERY CAP CONTACT MISSING CONFIRMED DUE TO A MISSING BATTERY CAP CONTACT. 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. 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 THAT THE BOLUS FEATURE WAS NOT WORKING IN THE PUMP AND EXPERIENCING HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED AND THE PUMP FAILED THE HIGH-PRESSURE TEST. NO FURTHER COMPLICATION REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP. THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573897 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL HG5AKWS 000000763000365905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown