BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3970025 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88390
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING A BASAL AND ON SEVERAL OTHER OCCASIONS. THE BLOOD GLUCOSE READING WAS 206 MG/DL. THE CUSTOMER STATED THAT 1 DAY AFTER AN INFUSION SET CHANGE, SHE PRIMED UPON DISCONNECTING TO MAKE SURE THE DEVICE WOULD WORK; NORMALLY THERE HAD BEEN SCENARIOS WHEN SHE WOULD FIND THAT THE INFUSION SET WAS KINKED, CAUSING THE INSULIN PUMP TO ALARM, BUT THIS WAS NOT THE CASE IN THIS EVENT. CUSTOMER WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL AND DECLINED RETURNING THE INFUSION SET AND RESERVOIR FOR ANALYSIS. SHE REPORTED THAT THE INFUSION SET CANNULA DID NOT SEEM BENT. ADVISED CUSTOMER TO CALL WHEN THE DEVICE IS ALARMING IN ORDER FOR PROPER TROUBLESHOOT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446596 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR