BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3930622 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86840
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    THE CUSTOMER REPORTED HAVING ISSUES WITH THE MIO INFUSION SETS. THE BLOOD GLUCOSE READING WAS 206MG/DL. THE CUSTOMER MENTIONED HAVING NO DELIVERY ALARMS, BUT THE ALARMS WERE SOLVED BY CHANGING THE INFUSION SET. HOWEVER, ONCE THE INFUSION SET WAS CHANGED AND THE SAME RESERVOIR WAS USED, STILL THE INSULIN WAS NOT ABLE TO PUSH THE INSULIN THROUGH. THE CUSTOMER WAS NOT ABLE TO DETERMINE THE PREVIOUS CAUSE FOR THE ALARMS. THE CUSTOMER DID NOT CALL BEFORE TO REPORT THE ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408845 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR