BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 10100859 · Received May 29, 2020

    Report

    Report Number
    2032227-2020-124284
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    May 25, 2020
    Report Date
    August 28, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000166519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED ALL FUNCTIONAL TESTING INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME OR SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DELIVERY ACCURACY TEST AT .08675 INCHES. NO UNDER DELIVERY ANOMALY NOTED DURING TESTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 579 AND 473 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER HAD BLOOD GLUCOSE LEVELS OF 141, 254, AND 300 MG/DL. CUSTOMER HAD HEADACHE. CUSTOMER WAS USING AUTO MODE. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THE CANNULA WAS BENT. CUSTOMER DECLINED TO CHECK AIR BUBBLES AND LEAK. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL EVENT. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564195 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG3KSKM 00763000166519

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other