BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4791001 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58771
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONED PROPERLY DURING TESTING. HOWEVER, THE INSULIN FOUND MOISTURE DAMAGE ON THE KEYPAD TRACES DURING VISUAL INSPECTION. THE INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW, AND SCRATCHED RESERVOIR TUBE WINDOW.

    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

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE EXPERIENCED KEYPAD ANOMALY. CUSTOMER REPORTED THAT BUTTONS WERE NOT WORKING CORRECTLY WHEN ATTEMPTS WERE MADE TO CLEAR AN ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 85 MG/DL. CUSTOMER DOES NOT KNOW WHAT CAUSED ANOMALY. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336190 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR