BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4820206 · Received June 4, 2015

    Report

    Report Number
    3004209178-2015-62768
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    March 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AND NO FAILED BATTERY TEST ALARM WAS NOTED DURING TESTING. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND SELF TEST. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST WHEN INSERTING A NEW BATTERY. THE CUSTOMER STATED THAT THE CAUSE OF THE ALARM MAY BE A CRACK ON THE INSULIN PUMP. THE CUSTOMER STATED THAT THE CRACK RAN ALONG THE BATTERY COMPARTMENT. THE CUSTOMER WAS UNAWARE OF HOW THE DAMAGE OCCURRED. THE CUSTOMER WAS ADVISED THAT IF THE FAILED BATTERY TEST ALARM WAS NOT CLEARED THEN THE ALARM WOULD RECUR WITH EACH NEW BATTERY INSERTED. THE CUSTOMER WAS ADVISED THAT THEIR INSULIN PUMP NEEDED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WAS INFORMED THE DEVICE WOULD BE REPLACED. THE CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361553 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR