BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161925 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36120
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER USED 2 INFUSION SETS AND RECEIVED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. CUSTOMER WAS ASSISTED IN PERFORMING A 5.0 UNIT FIXED PRIME BUT DID NOT SEE THE INSULIN EXIT AT ALL. CUSTOMER PUSHED INSULIN SLOWLY THROUGH THE TUBING AND THE INSULIN EXITED. CUSTOMER WAS ADVISED THAT THE PUMP WAS WORKING AS DESIGNED. IT WAS EXPLAINED THAT THE ALARM WAS CAUSED BY SET/RESERVOIR OCCLUSION. CUSTOMER WAS TREATED WITH AN IV DRIP AND MANUAL INJECTIONS FOR DIABETIC KETOACIDOSIS. CUSTOMER'S BLOOD SUGAR WAS OVER 600 MG/DL AND BLOOD CHEMISTRY WAS OFF. CUSTOMER STATED THERE WAS MUSCLE DAMAGE DUE TO DIABETIC KETOACIDOSIS AND A COUPLE CANNULAS DID NOT WORK SINCE THE HOSPITAL. CUSTOMER STATED THAT HE ALSO HAD A BLOOD GLUCOSE LEVEL OF 400 MG/DL AND TREATED FOR IT. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF THE HOSPITAL VISIT. CUSTOMER STATED THAT THE PUMP WAS NOT WORKING AT THE TIME. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644099 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR