BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3930630 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86817
    Event Type
    Injury
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 400 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP STOPPED READING THE BLOOD GLUCOSE LEVELS AND INSULIN ON (B)(6) 2014. THE CUSTOMER CHANGED THE INFUSION SET ONE DAY PRIOR TO CALLING, AND SHE ALSO REPORTED THAT THERE WAS A LOT OF BLOOD INSIDE THE TUBING AND AT THE INSERTION SITE. THERE WERE NO SYMPTOMS OF HIGH BLOOD GLUCOSE OBSERVED, AND THE CUSTOMER TREATED WITH MANUAL INJECTION. UPON TROUBLESHOOTING, THE CUSTOMER STATED THAT INSULIN DID EXIT THE TUBING; NO LEAK WAS FOUND. THE CUSTOMER CALLED AGAIN SEVERAL DAYS LATER FOR ASSISTANCE WITH TROUBLESHOOTING AND FOUND THAT THE DEVICE PASSED THE HIGH PRESSURE TEST AS DESIGNED. THE BLOOD GLUCOSE READING AT THE TIME OF THE SECOND CALL WAS 252 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408848 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR