BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4191119 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-98372
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MOTOR ERROR ALARM DURING NORMAL USE. THE BLOOD GLUCOSE READING WAS 110 MG/DL. THE INSULIN PUMP WAS NOT DROPPED OR EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. HE STATED THAT HE WAS ABLE TO REWIND THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670189 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR