BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3974234 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88862
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. NO UNEXPECTED LOW RESERVOIR ALARM OR EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. THE UNITS LEFT IN THE STATUS SCREEN MATCHES THE UNITS LEFT ON THE RESERVOIR. THE INSULIN PUMP HAD CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER WAS EXPERIENCING NO DELIVERY OF INSULIN. CUSTOMER REPORTED THAT HE ATTEMPTED TO DELIVER 5 UNITS OF INSULIN AS A TEST, BUT ONLY 1 UNIT DELIVERED. CUSTOMER'S BLOOD GLUCOSE AT THE TIME WAS AT 204 MGL/D. TROUBLESHOOTING PERFORMED SHOWED NO PROBLEM WITH THE INSERTION SITE. ADVISED INSULIN PUMP WILL BE REPLACED. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450000 530G INSULIN PUMP OZO OZO MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR