BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3941781 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87486
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    DURING A FOLLOW UP PHONE CALL THE CUSTOMER REPORTED THAT THE INSULIN PUMP WENT TO THRESHOLD SUSPENSE BECAUSE THE SENSOR INDICATED THAT THE CUSTOMER WAS HAVING LOW BLOOD GLUCOSE, WHICH WAS NOT THE CASE. THE CUSTOMER DID NOT RECALL THE EXACT BLOOD GLUCOSE VALUE BUT STATED THAT THE THRESHOLD SUSPEND WAS SET TO 60 MG/DL. THE BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS UNKNOWN. THE CUSTOMER ALSO STATED THAT THEY WERE HAVING TROUBLE WITH THE SENSOR AND GETTING IT TO WORK PROPERLY BECAUSE THE SENSOR WAS NOT STAYING IN SECURELY. BUT, THEY STATED THAT PUTTING EXTRA TAPE ON THE SENSOR SOLVED THE ISSUE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418870 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR