BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4211788 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-29322
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 28, 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

    (B)(4).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 IS REPORTED THAT A CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE OF LOW 20'S MG/DL. THE CUSTOMER WAS TREATED BY THE PARAMEDICS FOR THE LOW BLOOD GLUCOSE. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR LOW BLOOD GLUCOSE. THE CUSTOMER DOES NOT REMEMBER THE TIME AND DATE OF THE INCIDENT AND DID NOT WANT TO TROUBLE SHOOT THE INSULIN PUMP BECAUSE THE CUSTOMER STATES HE HAS NO ISSUES WITH IT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691538 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR