BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6194071 · Received December 21, 2016

    Report

    Report Number
    2032227-2016-51816
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 25, 2016
    Report Date
    November 25, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    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. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARMS. THE CUSTOMER'S BLOOD GLUCOSE WAS 230 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY TRIED DIFFERENT INFUSION SETS OR CANNULA LENGTHS. THE CUSTOMER STATED THAT THE INSULIN WAS NOT EXPIRED OR DENATURED. THE CUSTOMER STATED THAT THE SITES WERE ROTATED. THE CUSTOMER STATED THAT THE TUBING WAS NOT BENT OR KINKED. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR RECURRING ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847454 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR