BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3973919 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88914
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 2, 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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, NO DELIVERY AND MOTOR TESTS. NO MOTOR ERROR ALARM NOTED. THE DEVICE WAS MONITORED FOR 24 HRS AND NO UNEXPECTED AUTO OFF ALARM NOTED. THE UNIT HAD CRACKED BATTERY TUBE THREADS.

    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 CUSTOMER RECEIVED A MOTOR ERROR ALARM ON HIS INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS AT 199 MG/DL. THE MOTOR ERROR ALARM OCCURRED DURING NORMAL USE AND ALSO DURING BOLUS. THE CUSTOMER INSERTED A NEW SET AND WAS ABLE TO REWIND. IT WAS ALSO MENTIONED THAT THE CUSTOMER PREVIOUSLY USED LITHIUM BATTERIES, WHICH HEATED THE PUMP UP AND IT WAS EXPLAINED TO HIM THAT ALKALINE BATTERIES ARE RECOMMENDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451105 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR