BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4240461 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49717
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE HAD GONE UP TO OVER 500 MG/DL. AT THE TIME OF REPORTING, HER BLOOD GLUCOSE WAS 409 MG/DL. THE CUSTOMER STATED SHE HAD GOTTEN SOME NEW INSULIN BECAUSE SHE BELIEVED THE PREVIOUS BOTTLE MAY HAVE BEEN CLOUDY. HER SYMPTOMS OF HIGH BLOOD GLUCOSE INCLUDED EXCESSIVE FATIGUE AND THIRST AS WELL AS FREQUENT URINATION. THE CUSTOMER HAD BEEN TREATING WITH BOLUSES BUT HAD A SYRINGE AS A BACK-UP. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR BUBBLES WERE FOUND. INSULIN DID EXIT THE TUBING DURING A MANUAL PRIME AND NO LEAKS WERE FOUND. THE TIME AND DATE WERE INCORRECT AND THE CUSTOMER WAS ASSISTED IN CORRECTING THESE. THE HIGH PRESSURE TEST COULD NOT BE PERFORMED AS THE CUSTOMER DID NOT HAVE A TUBING CLAMP. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN AND TO TREAT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722697 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR