BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3942431 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87536
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW 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

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM. THE BLOOD GLUCOSE READING WAS 200 MG/DL. PRIOR TO THE EVENT, THE PATIENT WAS SEATED AND DID NOT DO ANYTHING TO THE INSULIN PUMP. IN TROUBLESHOOTING, THE CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM BUT THE PATIENT WAS UNABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419654 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR