BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751LNAS

    MDR report key: 7977434 · Received October 18, 2018

    Report

    Report Number
    2032227-2018-44969
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 14, 2018
    Report Date
    October 18, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169933224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 277 MG/DL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 348 MG/DL AT THE TIME OF INCIDENT. CUSTOMER ALSO HAD BLOOD GLUCOSE LEVEL WAS 230, 256 AND 387 MG/DL. THE CUSTOMER FEELS OK TO TROUBLESHOOTING HIGH BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THEY DID NOT CONTACTED THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818463 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAS A5751LNASJ 00643169933224

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other FRN RESUNOMED INFSET