BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4221755 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46707
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 NEEDED ASSISTANCE REWINDING AND PRIMING THE INSULIN PUMP. DURING THAT PROCESS, THE CUSTOMER RECEIVED A NO DELIVERY ALARM. CUSTOMER WAS NEW TO THE PUMP AND HIS BLOOD GLUCOSE LEVEL WAS 82 MG/DL. CUSTOMER MANUALLY PUSHED THE PLUNGER VERY SLOWLY AND VERIFIED THAT THE INSULIN EXITED THE TUBING. CUSTOMER RAN A MANUAL PRIME TO AT LEAST 5.0U AND THE PUMP ALARMED NO DELIVERY. CUSTOMER WAS ADVISED THAT THE PUMP WAS WORKING AS DESIGNED. CUSTOMER WAS ASSISTED WITH THE REWIND/PRIME PROCESS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702683 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR