BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4211981 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45055
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. NO UNEXPECTED LOW BATTERY ALARM WAS NOTED. ALL BUTTONS FUNCTIONED PROPERLY AND NO DAMAGE WAS NOTED ON THE KEYPAD ASSEMBLY. NO UNLOCKED KEYPAD CONNECTOR. THE INSULIN PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND A 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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LOW ALARM THAT SHE COULD NOT CLEAR. THE CUSTOMER STATED SHE HAD TRIED SIX OR SEVEN TIMES TO CLEAR THE ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 149 MG/DL. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693591 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR