BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5240971 · Received November 20, 2015

    Report

    Report Number
    2032227-2015-68156
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE RECENTLY WENT TO THE EMERGENCY ROOM DUE TO DIABETIC KETOACIDOSIS. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 600 MG/DL. THE CUSTOMER REPORTED THAT THE CANNULA WAS BENT. CUSTOMER STATED THAT SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT, BUT WAS LATER ASKED BY DOCTORS TO REMOVE IT. THE CUSTOMER ALSO STATED THAT SHE WOULD BE GOING THROUGH METAL DETECTORS DAILY FOR HER NEW JOB AND INQUIRED IF THIS WOULD DAMAGE THE INSULIN PUMP. THE INSULIN PUMP WAS NOT REPLACED OR RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771152 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention