BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142357 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33715
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THIS MDR RELATED TO THE (B)(4)MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP MAY NOT BE FUNCTIONING PROPERLY DUE TO HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED THEY WERE EXPERIENCING BLOOD GLUCOSE LEVELS AROUND 217 MG/DL, WHICH LED THEM TO BELIEVE THE DEVICE MAY NOT BE DELIVERING INSULIN. CUSTOMER ADVISED TO DISCONNECT FROM PUMP. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, THE RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND CUSTOMER VERIFIED DISPLAY SCREEN SHOWS CORRECT AMOUNT OF INSULIN. CUSTOMER VERIFIED DEVICE WAS NOT LEAKING AND DID NOT ALARM. INFORMED CUSTOMER THE DEVICE IS FUNCTIONING PROPERLY AND TO MONITOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621831 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR