BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 15038957 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-289557
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    March 18, 2020
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000192143
    Removal / Correction Number
    Z-0958-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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-0958-2020. (B)(4). S/W 4.11D. THE UNIT DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. UNIT 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 0.08730 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE CORNER OF THE BELT CLIP RAIL, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: THE FORMATTED HISTORY FILE LISTS DATA FROM 10/27/2018 TO 02/12/2020. 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

    ON 3/18/2020 16:19:53 PST ICE BATCH USER (BATCH_ICE), PHONE: (B)(6) COMPLAINT: (B)(4), COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: (B)(6), CUSTOMER DECEASED. RELATIVES WILL SEND PUMP BACK. COUNTRY: GERMANY, CITY: (B)(6). INPUT DATE: 03/18/2020, WARRANTY START: 01/09/2019, WARRANTY END: 01/08/2023, BATCH - NG1698988H. ON 05/08/2020 16:51:40 PST ICE BATCH USER (BATCH_ICE), PHONE (B)(6), COMPLAINT: (B)(4), COMPLAINT STATUS: COMPLETED, MDT INITIAL CONTACT: (B)(6), GFE: SECOND REMINDER LETTER SENT ON THE 08TH MAY 2020. 08.05.20. (B)(6) GFE: FIRST REMINDER LETTER SENT ON THE 24TH APRIL 2020. 24.04.20. (B)(6). CUSTOMER DECEASED. RELATIVES WILL SEND PUMP BACK. COUNTRY: GERMANY, CITY: (B)(6), INPUT DATE: 03/18/2020 ,WARRANTY START: 01/09/2019 WARRANTY END: 01/08/2023 BATCH - NG1698988H. ON 05/22/2020 16:37:01 PST ICE BATCH USER (BATCH_ICE), PHONE (B)(6), COMPLAINT: (B)(4), COMPLAINT STATUS: COMPLETED MDT INITIAL CONTACT: (B)(6), GFE: CUSTOMER SENT PUMP BACK ON 05TH MAY 2020 WITH (B)(6). ON 22.05.20 (B)(6) GFE: SECOND REMINDER LETTER SENT ON THE 08TH MAY 2020. 08.05.20 (B)(6) GFE: FIRST REMINDER LETTER SENT ON THE 24TH APRIL 2020. 24.04.20. (B)(6) CUSTOMER DECEASED. RELATIVES WILL SEND PUMP BACK. COUNTRY: GERMANY CITY: (B)(6). INPUT DATE: 03/18/2020 WARRANTY START: 01/09/2019 WARRANTY END: 01/08/2023 BATCH - NG1698988H. ON 05/22/2020 16:37:01 PST ICE BATCH USER (BATCH_ICE), PHONE (B)(6), COMPLAINT: (B)(4), COMPLAINT STATUS: COMPLETED MDT INITIAL CONTACT: (B)(6). GFE: CUSTOMER SENT PUMP BACK ON 05TH MAY 2020 WITH (B)(6). ON 22.05.20 (B)(6) GFE: SECOND REMINDER LETTER SENT ON THE 08TH MAY 2020. 08.05.20 (B)(6) GFE: FIRST REMINDER LETTER SENT ON THE 24TH APRIL 2020. 24.04.20 (B)(6) CUSTOMER DECEASED. RELATIVES WILL SEND PUMP BACK. COUNTRY: GERMANY CITY: (B)(6), INPUT DATE: 03/18/2020 WARRANTY START: 01/09/2019, WARRANTY END: 01/08/2023, BATCH - NG1698988H, 06/18/2020 10:05:54 PST (B)(6). RMA CREATED INCORRECTLY. RMA DELETED AND NEW REPAIR/RETURN (ZRCI) CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872660 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG2VU53 00763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death