BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4112222 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-22963
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WAS 525 MG/DL. IT WAS STATED THAT THERE WERE AIR BUBBLES ALONG THE TUBING OF HER INSULIN INFUSION SET. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THE INSULIN PUMP WAS NOT REWOUND WITH THE RESERVOIR IN PLACE. SHE WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND DELIVER A 5 UNIT FIXED PRIME UNTIL AIR BUBBLES WERE NO LONGER VISIBLE. THE CUSTOMER WAS THEN ADVISED TO CHANGE THE FIXED PRIMAMOUNT BACK TO THE APPROPRIATE CANNULA PRIME AMOUNT FOR THE INFUSION SET, AND IT WAS REPROGRAMMED TO 0.3 UNITS. THE CUSTOMER STATED THE INSULIN HAD BEEN STORED AT ROOM TEMPERATURE. IT WAS VERIFIED THAT THERE WAS NO AIR IN THE TUBING. THE CUSTOMER STATED THERE WERE NO LEAKS IN THE TUBING, AFTER ANOTHER FIXED PRIME WAS PERFORMED. AFTER CHANGING THE INFUSION SET, THE AIR BUBBLES DID NOT PERSIST. THE CUSTOMER RECEIVED A NO DELIVERY ALARM DURING A MANUAL PRIME ON THE NEW SET AND NOTICED A BIG AIR BUBBLE IN ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592460 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR UNOMEDICAL INSULIN INFUSION SET