BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 11998104 · Received June 15, 2021

    Report

    Report Number
    2032227-2021-156838
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 9, 2021
    Report Date
    April 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000643169939219
    Removal / Correction Number
    Z-0956-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0956-2020. 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

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED KEYPAD OVERLAY, A MISSING RESERVOIR TUBE O-RING, A BROKEN RESERVOIR TUBE LIP, A MISSING RETAINER, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT, A PILLOWING KEYPAD OVERLAY AND A SERIAL NUMBER LABEL FADING. THE INSULIN PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. THE TEST P-CAP/RESERVOIR DOES NOT LOCK IN PLACE AND UNABLE TO PERFORM THE DISPLACEMENT TEST, DISPLACEMENT ACCURACY TEST AND OCCLUSION TEST DUE TO MISSING RETAINER, MISSING RESERVOIR TUBE O-RING AND BROKEN RESERVOIR TUBE LIP. ALL CURRENTS WITHIN SPECIFIC RANGE. THE INSULIN PUMP WAS MONITORED AND NO UNEXPECTED FAILED BATTERY TEST OR BATTERY FAILED ALERT NOTED DURING TESTING. UNABLE TO REWIND AND PERFORM REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, AND FORCE SENSOR TEST DUE TO PUMP ERROR 37 ALARM. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. HOWEVER, DURING VISUAL INSPECTION, CORROSION WAS FOUND ON THE ELECTRICAL BOARD 1. MOISTURE DAMAGE WAS ALSO FOUND ON THE VIBRATOR AND BATTERY TUBE. NO MOISTURE DAMAGE FOUND ON THE MOTOR AND KEYPAD ASSEMBLY. BY USING A TEST ELECTRICAL BOARD 1, THE INSULIN PUMP WAS ABLE TO REWIND SUCCESSFULLY. NO UNEXPECTED PUMP ERROR 37 ALARM NOTED DURING THE TESTING. THE ORIGINAL ELECTRICAL BOARD 1 WAS CLEANED AND THE INSULIN PUMP PASSED REWIND TEST. IN CONCLUSION, PUMP ERROR 37 ALARM DURING REWIND DUE TO CORROSION ON ELECTRICAL BOARD 1. 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 ALARM AND THERE WAS CRACK ON THE BATTERY SIDE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902742 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2BYHB 000000643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male