BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5143127 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-56152
    Event Type
    Injury
    Date Received
    October 10, 2015
    Date of Event
    September 27, 2015
    Report Date
    September 27, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS BLOOD GLUCOSE EXCEEDED 400 MG/DL AND THAT HE WAS ABOUT TO INSERT HIS FOURTH INFUSION SET OF THE DAY. THE PUMP HAD BEEN ALARMING WITH NO DELIVERY ALARMS SINCE THE FIRST SET WHEN HE WOKE UP IN THE MORNING. HE INSPECTED THE CANNULAS OF HIS FIRST THREE INFUSION SETS AND NONE OF THEM WERE BENT. THE CUSTOMER WAS ALSO ABLE TO SUCCESSFULLY PRIME WITH EACH SET. HIS BLOOD GLUCOSE KEPT CLIMBING SINCE NOON. HIS BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 212 MG/DL BUT BY THE TIME HE CALLED IT WAS 386 MG/DL. THE CUSTOMER NOTED ABDOMINAL PAIN AND THINNER BREATHING AS SYMPTOMS OF HIS HYPERGLYCEMIA. TROUBLESHOOTING WAS INITIATED FOR THE HIGH BLOOD GLUCOSE. NO APPARENT DAMAGE WAS FOUND ON THE PUMP. THERE WERE NO AIR BUBBLES IN THE TUBING. A HIGH PRESSURE TEST COULD NOT BE PERFORMED DUE TO LACK OF A TUBING CLAMP. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT AS USUAL. THE INSULIN PUMP WAS NOT SHIPPED OR RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673804 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other