BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15026662 · Received July 15, 2022

    Report

    Report Number
    2032227-2022-287707
    Event Type
    Death
    Date Received
    July 15, 2022
    Date of Event
    February 2, 2020
    Report Date
    July 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Removal / Correction Number
    H9: Z-0956-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. Z-0956-2020. (B)(4) S/W 3.18E. THE INSULIN PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT TEST AT 0.08740 INCHES. INSULIN PUMP UPLOADED PROPERLY USING CARELINK. INSULIN PUMP HAD SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: 01/22/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 28.4 01/23/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 28.4 01/24/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 28.4 01/25/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 28.4 01/26/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 28.4 01/27/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 24.05 01/28/2020 DAILY TOTAL OF ALL INSULIN DELIVERED = 0 THERE WAS NO DATA LISTED AFTER 01/28/2020. CUSTOMER PASSING: (B)(6) 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.

    Description of Event or Problem · 0

    COMPLAINTS TEXT 05/02/2020 06:53:54 (B)(6) I MARKED THE ACCOUNT INACTIVE/DECEASED. I OPTED OUT OF MARKETING/ACCOUNT COMM. PREF. COMPLAINTS TEXT 05/02/2020 06:53:35 (B)(6) BLOCKING ZRPL ORDER 5900987969 FOR PUMP RETURN. CREATING A NEW ZRCI ORDER 5900989165 TO PROPERLY RECEIVE IN DEVICE. COMPLAINTS TEXT 05/01/2020 09:30:05 ERP_RFC_USER RELATED SVN (B)(4) COMPLAINTS TEXT 05/01/2020 09:20:41 ERP_RFC_USER RELATED SVN (B)(4) COMPLAINTS TEXT 05/01/2020 09:15:29 ERP_RFC_USER RELATED SVN (B)(4) COMPLAINTS TEXT 05/01/2020 09:15:12 (B)(6) CHANGED EMAIL ON ORDER TO (B)(6) COMPLAINTS TEXT 05/01/2020 09:10:31 (B)(6) CHANGED NUMBER ON ORDER TO 609-480-9453 COMPLAINTS TEXT 05/01/2020 09:00:06 AGNEWE1 INITIAL NOTES: I CALLED A FEW DAYS AGO INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: HIS WIFE HAD PASSED AND IS REPORTING IT DECEASED REPORTING PER (B)(4). FIRST AND LAST NAME OF PERSON REPORTING EVENT: (B)(6). BEST PHONE NUMBER TO REACH PERSON REPORTING EVENT: (B)(6). RELATIONSHIP OF PERSON REPORTING EVENT TO THE DECEASED: HUSBAND . REPORTING PARTY IS AWARE OF THE DECEASED EVENT DETAILS. DATE OF CUSTOMER PASSING: (B)(6) 2020. CAUSE OF CUSTOMER PASSING AS INDICATED BY REPORTING PARTY: ACUTE RESPORTIALY . LOCATION OF CUSTOMER¿S PASSING: HOSPITAL . DATE CUSTOMER WAS ADMITTED TO HOSPITAL, EMERGENCY ROOM OR HOSPICE (IF KNOWN): (B)(6) 2020. BG AT TIME OF ADMISSION TO HOSPITAL, HOSPICE AND/OR EMERGENCY ROOM, (IF KNOWN): UNKNOWN. DOES REPORTING PARTY INDICATE OTHER HEALTH ISSUES OR ILLNESS THAT MAY HAVE CONTRIBUTED OR LED UP TO PASSING? PNAOMIA AND ACUTE RESPORTY . DOES REPORTING PARTY RECALL THE INITIAL ONSET OR TIMEFRAME OF HEALTH ISSUE OR ILLNESS? (B)(6) 2020. WAS PUMP WORN AT THE TIME OF PASSING? NO. DATE THE PUMP WAS LAST WORN: (B)(6) 2020. REASON CUSTOMER WAS NOT WEARING PUMP AT TIME OF DECEASED EVENT: SHE HAD UNLINING ISSUES WITH RESPORTAY. DOES REPORTING PARTY KNOW IF CUSTOMER WAS OFF PUMP THERAPY DUE TO OTHER HEALTH ISSUE OR ILLNESS? YES. PUMP MATERIAL NUMBER: MMT-1780KPK. PUMP SERIAL NUMBER: (B)(4). INFUSION SET MATERIAL NUMBER: MMT-943. INFUSION SET LOT/BATCH: 5270483. RESERVOIR MATERIAL NUMBER: MMT-332A. RESERVOIR LOT/BATCH: HG3DEZJ. NAME OF GLUCOMETER BEING WORN OR USED ((B)(4), LIFESCAN, ETC.): UNKNOWN . WAS MEDTRONIC CGM INCLUDED IN DIABETES THERAPY? NO. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: HUSBAND IS RTN PUMP ADDITIONAL NOTES: HE SAID THAT HE CALLED A FEW DAYS AGO TO REPORT HIS WIFES PASSING HE IS WANTING TO SEE ABOUT THE PUMP AND LEFT OVER SUPPLIES SHIP: BOX LE /RETURN: PUMP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967016 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG23D2K 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death