BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4182616 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39856
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND A 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER INSULIN PUMP NEEDS TO BE REPLACED. SHE HAS HAD ISSUES WHERE ONE DAY THE DEVICE WILL WORK FINE, BUT THE OTHER DAY IT WILL NOT DELIVER ANY INSULIN. THE DEVICE DOES NOT HAVE ANY ALARMS. CUSTOMER'S BLOOD GLUCOSE GOES UP AND DOES NOT GO DOWN. CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL. SHE HAS CALLED IN BEFORE FOR TROUBLESHOOTING. SHE WAS SENT A TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST, BUT CUSTOMER HAS NOT DONE SO. SHE WAS ALSO SENT DIFFERENT CANNULA LENGTHS TO SAMPLE BUT SHE HAS NOT TRIED THEM. THE DEVICE IS BEING REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660336 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention