BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103598 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26461
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE RECEIVED A NO DELIVERY ALARM ON HER INSULIN PUMP AND INSULIN WAS NOT DELIVERING. SHE STATED THAT AFTER CHANGING OUT THE INFUSION SET, SHE RECEIVED ANOTHER NO DELIVERY ALARM DURING A BOLUS DELIVERY ATTEMPT. THE CUSTOMER'S BLOOD GLUCOSE WAS 454 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. TROUBLESHOOTING ASSISTANCE WAS PROVIDED. THE CUSTOMER PERFORMED A 5.0 UNIT FIXED PRIME AND INSULIN DID EXIT. THE CUSTOMER REMOVED THE INFUSION SET TO EXAMINE THE CANNULA, WHICH WAS NOT BENT. IT WAS EXPLAINED THERE MAY BE A POSSIBLE SITE-RELATED ISSUE, POSSIBLY DUE TO A SITE OR SET OCCLUSION. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET AND PERFORMED A 5 UNIT FIXED PRIME. INSULIN EXITED. IT WAS EXPLAINED THE SITE MAY HAVE BEEN OCCLUDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582281 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR UNOMEDICAL INSULIN INFUSION SET