BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4022220 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-95744
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON THE NIGHT BEFORE THE INSULIN PUMP ALARMED NO DELIVERY WHEN TRYING TO DELIVER AN INSULIN BOLUS. CUSTOMER WAS INSTRUCTED TO CHANGE THE INFUSION SET AND NOTICED THAT THE CANNULA WAS BENT; CUSTOMER HAD TO TREAT WITH INSULIN MANUAL INJECTION. CUSTOMER STATED THAT HE IS RECEIVING A NO DELIVERY ALARM AGAIN. BLOOD GLUCOSE IS 291 MG/DL. CUSTOMER FELT WELL. DURING TROUBLESHOOT FOR HIGH BLOOD GLUCOSE; CUSTOMER DISCONNECTED FROM THE INSULIN PUMP. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. NO AIR FOUND IN TUBING. MANUAL PRIME PERFORMED AND INSULIN DID EXIT THE TUBING. NO INSULIN LEAK FOUND. TIME, DATE BASAL AND BOLUS ARE CORRECT. DEVICE PASSED THE HIGH PRESSURE TEST. THE INFUSION SET WAS REMOVED AND THE CANNULA IS NO BENT BUT IT IS OCCLUDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499060 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB A3751NABJ

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR UNOMEDICAL INSULIN INFUSION SET