BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 15038560 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-290272
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    July 20, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. RECALL: 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 0.0875 INCHES. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD SCRATCHED CASE, STAINED SERIAL NUMBER LABEL, 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 03/21/2020 TO 07/18/2020. 07/12/2020 DAILYTOTALOFALLINSULINDELIVERED = 35.85. 07/13/2020 DAILYTOTALOFALLINSULINDELIVERED = 36.775. 07/14/2020 DAILYTOTALOFALLINSULINDELIVERED = 33.15. 07/15/2020 DAILYTOTALOFALLINSULINDELIVERED = 31.85. 07/16/2020 DAILYTOTALOFALLINSULINDELIVERED = 31.6. 07/17/2020 DAILYTOTALOFALLINSULINDELIVERED = 31.75. 07/18/2020 DAILYTOTALOFALLINSULINDELIVERED = 18.5.

    Description of Event or Problem · 0

    ON (B)(6) 2020 17:24:39 PST ICE BATCH USER (BATCH_ICE) PHONE (B)(6), COMPLAINT: (B)(4). COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: (B)(6) TAKEN BY: NIESSS2 "CUSTOMER DECEASED NO FURTHER INFORMATION WAS GIVEN DUE TO DATA PROTECTION. RETURN PUMP. (Z101 + HC DEATH N/A) " COUNTRY: GERMANY CITY: BERGISCH GLADBACH ZIP: 51429 INPUT DATE: (B)(6) 2020, WARRANTY START: 03/08/2017, WARRANTY END: 03/07/2021, BATCH - NG1976751H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111701 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG3KVGL 00763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death