BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 10306209 · Received July 21, 2020

    Report

    Report Number
    2032227-2020-150267
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    July 14, 2020
    Report Date
    October 13, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000166526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS ORIGINALLY ANALYZED UNDER MDR NUMBER 2032227-2020-160674. UNIT RECEIVED WITH MISSING RETAINER RING AND RESERVOIR TUBE LIP O-RING. UNABLE TO PERFORM DISPLACEMENT TEST AND P-CAP / RESERVOIR WILL NOT LOCK PROPERLY DUE TO MISSING RETAINER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE AUTO MODE INFORMATION PROVIDED WITH INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN PROVIDED IN THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE IN EMERGENCY ROOM DUE TO HYPERGLYCEMIA ON UNKNOWN DATE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT TIME OF INCIDENT. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 416 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP'S CLEAR PLASTIC RING WAS BROKEN. IT WAS UNKNOWN THAT AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER WAS USING DEXCOM SENSOR HENCE AUTO MODE WAS NOT IN USE AT THE TIME OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764582 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG3H44P 00763000166526

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization FRN-MMT-332-RSVR, UNOMED INF SET