BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 15039214 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-288618
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    March 29, 2020
    Report Date
    July 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000090197
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. RECALL: Z-0955-2020. (B)(4). S/W 4.10C. DEVICE RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED. DEVICE 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 DELIVERY ACCURACY TEST AT 0.08730 INCHES. DEVICE UPLOADED PROPERLY USING CARELINK. DEVICE HAD SCRATCHED CASE, FADED 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: 03/23/2020 DAILYTOTALOFALLINSULINDELIVERED = 91.9. 03/24/2020 DAILYTOTALOFALLINSULINDELIVERED = 96.85. 03/25/2020 DAILYTOTALOFALLINSULINDELIVERED = 117.5. 03/26/2020 DAILYTOTALOFALLINSULINDELIVERED = 98.05. 03/27/2020 DAILYTOTALOFALLINSULINDELIVERED = 87.15. 03/28/2020 DAILYTOTALOFALLINSULINDELIVERED = 89.05. 03/29/2020 DAILYTOTALOFALLINSULINDELIVERED = 72.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2020. THE CAUSE OF DEATH WAS ACUTE CORONARY/UNSTABLE ANGINA. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER RETURNED THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2892058 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG2EGTH 00763000090197

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death