BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4244001 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50750
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. NO DISPLAY ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A BUTTON ERROR ALARM. CUSTOMER REPORTED THAT THE NUMBERS ON THE SCREEN WERE RAMPING DURING BOLUS. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARM. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725255 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR