BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945552 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87854
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ELECTRONIC ASSEMBLY. UNABLE TO VERIFY BATTERY OUT LIMIT ALARM AND OFF NO POWER ALARM DUE TO BLANK DISPLAY. INSULIN PUMP HAD CRACKED DISPLAY WINDOW CORNER AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP TURNED OFF AND THE DISPLAY WENT BLANK WITHOUT A LOW BATTERY ALERTING. THE CUSTOMER STATED THAT THIS WAS THE SECOND TIME. THE CUSTOMER CHANGED THE BATTERY AND THE DEVICE REBOOTED. IT MIGHT HAVE GIVEN AN OFF NO POWER ALERT. THE CUSTOMER'S BLOOD GLUCOSE WAS 110 MG/DL. THE CUSTOMER WAS CALLING AFTER RECEIVING A NEW BATTERY CAP. IN THE ALARM HISTORY OF THE DEVICE THERE WAS A BATTERY OUT LIMIT ALERT. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424385 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR