BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4213449 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43263
    Event Type
    Malfunction
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, COMPROMISED FORCE SENSOR, AND NO DELIVERY TEST. THERE WAS NO MOTOR ERROR ALARM NOTED. THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTES TO HAVE RECEIVED TWO MOTOR ERROR ALARMS. CUSTOMER'S BLOOD GLUCOSE WAS 258 MG/DL. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680677 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR