BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 13760466 · Received March 14, 2022

    Report

    Report Number
    2032227-2022-136123
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    January 2, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000393786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 0

    RETAINER RING =BLACK. CUSTOMER RETURNED INSULIN PUMP DUE TO LOW BG'S AND EXPOSURE TO AN ELECTRO MAGNETIC FIELD (EMF) ON EVENT DATE 02-JAN-2022. DEVICE PASSED THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST AND ACTIVE CURRENT MEASUREMENT TEST. DEVICE PASSED DELIVERY ACCURACY TEST AT 0.08735 INCHES. UNABLE TO VERIFY LOW BG'S OR EXPOSURE TO AN EMF. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE) AND DAMAGED DISPLAY WINDOW COVER. DEVICE PASSED FULL FUNCTION TESTS. UNABLE TO VERIFY LOW BF'S OR EXPOSURE TO EMF. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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

    MEDTRONIC RECEIVED INFORMATION THAT EXPOSED TO MAGNETIC FIELD OR MRI OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338318 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG583RK 000000763000393786

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown