BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132168 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30991
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. 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

    IT WAS REPORTED BY THE CUSTOMER THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OF 325 MG/DL. ADVISED CUSTOMER TO DISCONNECT FROM DEVICE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, CUSTOMER WAS ASKED TO CHECK FOR AIR BUBBLES IN INFUSION SET TUBING. CUSTOMER VERIFIED THERE WERE NO AIR BUBBLES PRESENT. AFTERWARDS, THE RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. DEVICE PASSED PRIMING, HIGH PRESSURE TEST AND INSULIN EXITED TUBING. CUSTOMER VERIFIED DEVICE WAS NOT LEAKING AND DID NOT ALARM. ADVISED CUSTOMER THE DEVICE IS FUNCTIONING PROPERLY AND TO MONITOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612295 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR