BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4240452 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49707
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP GAVE A MOTOR ERROR ALARM DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. UNABLE TO PERFORM THE DISPLACEMENT TEST OR VERIFY ERROR ALARMS DUE TO THE MOTOR ERROR ALARMS. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE ALARMS ON THE INSULIN PUMP, INCLUDING A MOTOR POSITION ENCODER ERROR AND A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 112 MG/DL. THE MOTOR ERROR ALARM WAS RECEIVED DURING BASAL RATE INSULIN DELIVERY. THE CUSTOMER STATED THAT SHE HAD BEEN NEAR MAGNETS AT WORK ON OCCASION. SHE WAS NOT USING THE SENSOR FEATURE ON THE INSULIN PUMP AND WAS ABLE TO COMPLETE THE REWIND SEQUENCE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722694 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR