BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972143 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05120
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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

    CUSTOMER REPORTED THAT THE BOLUSES DID NOT GET DELIVERED. CUSTOMER HAD TREATED WITH MANUAL INJECTIONS. THE BLOOD GLUCOSE READING AT THE TIME OF THE REPORT WAS 158 MG/DL. CUSTOMER STATED THAT SHE BELIEVED THE BOLUSES DID NOT DELIVER BECAUSE HER BLOOD GLUCOSE HAD BEEN AS HIGH AS 400 MG/DL. SHE STATED THAT SHE HAD FORGOTTON TO FILL THE CANNULA DEAD SPACE AFTER REMOVING THE INTRODUCER NEEDLE. CUSTOMER USES DIFFERENT KINDS OF INFUSION SETS AND WAS ADVISED TO ENSURE SHE CHANGES THE THE FILL CANNULA AMOUNTS WHEN SHE SWITCHES THE SET TYPE. THE BOLUS WIZARD SETTINGS WERE ALL CORRECT. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. SHE STATED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL AND RECESSED. CUSTOMER FOUND THAT THERE WERE VERY TINY AIR BUBBLES IN THE TUBING, BUT DID NOT FIND ANY LEAK. CUSTOMER RAN A MANUAL PRIME AND STATED THAT INSULIN DID EXIT FROM THE TUBING. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448322 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR