BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5336925 · Received December 30, 2015

    Report

    Report Number
    2032227-2015-79896
    Event Type
    Injury
    Date Received
    December 30, 2015
    Date of Event
    December 17, 2015
    Report Date
    December 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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

    THE CUSTOMER'S IWFE REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 511 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 420 MG/DL. CUSTOMER TREATED THEIR BLOOD GLUCOSE WITH THE INSULIN PUMP.. IT WAS ALSO FOUND THE CUSTOMER WAS FEELING NAUSEOUS DUE TO THEIR HIGH BLOOD GLUCOSE. TROUBLESHOOTING DID NOT FIND ANY LEAKS OR AIR BUBBLES PRESENT. IT WAS ALSO FOUND THE CUSTOMER DID NOT HAVE A BENT CANNULA AFTER REMOVING THEIR INFUSION SET. CUSTOMER WAS ADVISED TO CALL BACK TO COMPLETE THE HIGH PRESSURE TEST. THE CUSTOMER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857532 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other