BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4081432 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21268
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    July 5, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. 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).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED. MOTOR TEST AND REWIND FUNCTIONED PROPERLY DURING TESTING. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, AND RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER RECEIVED A MOTOR ERROR ALARM ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 187 MG/DL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD HAVE LED TO THE ISSUE. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A NEW PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562552 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR