BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4942623 · Received July 27, 2015

    Report

    Report Number
    3004209178-2015-77937
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. NO PRIME ALARM NOTED. THE INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL AT THE TIME. CUSTOMER LEFT THE PUMP IN THE CAR AND WENT BIKING. CUSTOMER STATED THAT THE CAR WAS PARKED IN THE SHADE AND ABOUT AN HOUR LATER WHEN HE TRIED TO REFILL THE RESERVOIR, HE RECEIVED THE ALARM. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487796 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR