BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161991 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36075
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 THAT THE CUSTOMER HAD A NO DELIVERY ALARM ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 279 MG/DL. CUSTOMER TREATED WITH THE PUMP BUT WAS NOT SURE IF ALL THE INSULIN DELIVERED DUE TO THE ALARM. CUSTOMER CHECKED THE BOLUS HISTORY AND FOUND THAT NOT ALL OF THE BOLUSES DELIVERED. CUSTOMER GAVE A MANUAL INJECTION. CUSTOMER CHANGED THE FILL CANNULA TO 0.5U. CUSTOMER STATED THAT THE INSULIN DID EXIT. CUSTOMER WAS UNABLE TO REMOVE THE SET AT THIS TIME TO EXAMINE THE CANNULA. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET. IT WAS EXPLAINED THAT THERE MIGHT HAVE BEEN A POSSIBLE SITE RELATED ISSUE, POSSIBLY DUE TO A BENT CANNULA OR SITE/SET OCCLUSION. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644329 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH A3751NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR