BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4211937 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44725
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    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. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSULIN PUMP ALARMED WEAK SIGNAL. CUSTOMER STATED IT TAKES SO LONG TO CALIBRATE WHEN SHE GETS A METER READING AND WHEN SHE REPEATS THE READINGS WILL BE OFF BY 15-20 MG/DL. CUSTOMER NOTICED THE DIFFERENCE WHEN THE INSULIN PUMP GIVES A LOW PREDICTED ALARM. CUSTOMER MENTIONED THE INSULIN PUMP ALARMED THRESHOLD SUSPENSE BUT HER BLOOD GLUCOSE WAS 80 MG/DL. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 92 MG/DL. CUSTOMER UNABLE TO TROUBLESHOOT DUE TO SENSORS EXPIRED AND HAS NOT INSERTED NEW ONE. ADVISED THE CUSTOMER TO MONITOR AND REPORT BACK FOR ANY ISSUES. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692940 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR