BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4141926 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33219
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL INCLUDING DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TESTS. NO EXCESSIVE NO DELIVERY ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    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 THAT THE INSULIN PUMP WAS RETURNING NO DELIVERY ALARMS. BLOOD GLUCOSE LEVEL WAS 448 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL ABOVE 400 MG/DL THE NIGHT BEFORE THE CALL. CUSTOMER STATED THAT SHE ADMINISTERED A BOLUS, WENT TO SLEEP, AND WOKE UP WITH A BLOOD GLUCOSE LEVEL OF 448 MG/DL. REVIEW OF THE INSULIN PUMP'S HISTORY SHOWED THAT MULTIPLE NO DELIVERY ALARMS HAD BEEN RETURNED RECENTLY. CUSTOMER ALSO REPORTED SEEING AN AIR BUBBLE IN THE TUBING. TROUBLESHOOTING SHOWED THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621520 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR