BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3984631 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90618
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING REWIND, BASIC OCCLUSION, OCCLUSION, PRIME A/33, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS. NO UNEXPECTED EXCESSIVE NO DELIVERY ALARM. NO MOTOR ERROR ALARM, MOTOR PASSED MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBES THREADS 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

    CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE AND RECEIVING A NO DELIVERY ALARM AND MOTOR ERROR ALARMS ON THE INSULIN PUMP. SHE STATED THAT THERE WERE TWO MOTOR ERROR ALARMS THAT OCCURRED DURING PRIMING. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. SHE WAS ASSISTED IN CLEARING THIS ALARM AND STATED THAT SHE WAS ABLE TO REWIND THE INSULIN PUMP. CUSTOMER DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE AND NO DELIVERY ALARM BECAUSE THOSE ISSUES HAD BEEN RESOLVED WITH A COMPLETE SET CHANGE. THE BLOOD GLUCOSE READING WAS 259 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460021 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR