BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4252221 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52825
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN HAD A BLANK DISPLAY DUE TO A CORRODED BATTERY TUBE. THE FUNCTIONAL TESTS COULD NOT BE PERFORMED DUE TO THE BLANK DISPLAY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP.

    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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A BLANK SCREEN AND A MOTOR ERROR ALARM DURING BASAL. CUSTOMER'S BLOOD GLUCOSE WAS 175 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT CUSTOMER WAS NOT EXPOSED TO MAGNETIC FIELD OR MRI. CUSTOMER DOES USE SENSOR FEATURES. CUSTOMER IS ABLE TO COMPLETE REWIND SEQUENCE. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736382 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR