BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132250 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31021
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, SCRATCHES ON THE RESERVOIR TUBE WINDOW AND A STAINED END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WAS 441 MG/DL, WHICH SHE TREATED WITH AN INJECTION PEN. THE CUSTOMER STATED HER BLOOD GLUCOSE WAS AT 419 MG/DL EARLIER AFTER SHE ATE, SHE GAVE HERSELF A BOLUS AND LATER IT WAS AT 441 MG/DL, WHEN SHE GAVE HERSELF THE PEN INJECTION. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR WAS FOUND IN THE TUBING. INSULIN EXITED THE TUBING DURING A MANUAL PRIME AND NO LEAKS WERE FOUND. SETTINGS WERE CORRECT. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. UPON REMOVAL OF THE INFUSION SET, THE CANNULA WAS FOUND NOT TO BE BENT. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WAS FUNCTIONING AS DESIGNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612590 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR