BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6194022 · Received December 21, 2016

    Report

    Report Number
    2032227-2016-51895
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 26, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 580 MG/DL. THE CUSTOMER HAD SYMPTOMS SUCH AS VOMITING AND TREATED WITH A BOLUS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 494 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THE CANNULA WAS SLIGHTLY BENT. THE CUSTOMER DID NOT TROUBLESHOOT AND DID NOT SEND THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844989 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other