BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170389 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37782
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 HAD WEAK SIGNAL AND CUSTOMER HAD LOW BLOOD GLUCOSE. CUSTOMER STATED THAT SHE WAS RECEIVING WEAK SIGNAL, CALIBRATION ERROR AND CHANGE SENSOR. TROUBLESHOOTING WAS DONE FOR WEAK SIGNAL. CUSTOMER'S BLOOD GLUCOSE WAS 35 MG/DL. CUSTOMER TREATED WITH YOGURT AND GLUCOSE TABLETS. CUSTOMER HAD LOW BLOOD GLUCOSE AND AFTER RECHECKING HER BLOOD GLUCOSE IS NOW IN EIGHTIES. CUSTOMER DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651230 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR