BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3801108 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84515
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. A TEST TRANSMITTER CALIBRATED AND COMMUNICATED PROPERLY WITH THE DEVICE. PROGRAMMED SENSOR GLUCOSE VALUES REGISTERED PROPERLY IN THE SENSOR UPDATE HISTORY SCREEN.

    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 UNDER-DELIVERS INSULIN. DURING TROUBLESHOOTING THE INSULIN PUMP WORKS, BUT WHEN CUSTOMER CONNECTS THE INSULIN PUMP TO BODY; NO INSULIN DELIVERY. THIS HAS BEEN HAPPENING FOR FOUR DAYS. CUSTOMER STOPPED WEARING THE INSULIN PUMP. THE BLOOD GLUCOSE LEVEL ROSE TO OVER 600 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTIONS. CUSTOMER DID NOT GO TO HOSPITAL. CUSTOMER REQUESTED A REPLACEMENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277461 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR