BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972308 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88725
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE LEVEL OF 500 MG/DL. PRIOR TO THE HOSPITALIZATION CUSTOMER WAS RUNNING HIGH WITH A BLOOD GLUCOSE LEVEL OF 400 MG/DL AND RECEIVED A NO DELIVERY ALARM. CUSTOMER DID A SET CHANGE TO RESOLVE THE ALARM, BUT BLOOD GLUCOSE LEVEL CONTINUED TO RISE. A FEW DAYS LATER THE CUSTOMER CALLED TO COMPLETE TROUBLESHOOTING AND BLOOD GLUCOSE LEVEL WAS 258 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448315 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization