BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4203531 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-31664
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE THINKS HER INSULIN PUMP IS MALFUNCTIONING. SHE HAS HAD HIGH BLOOD GLUCOSE ALL DAY. SHE WOULD TREAT WITH THE DEVICE AND HER BLOOD GLUCOSE WOULD LOWER. CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL. SHE TREATED WITH THE DEVICE AND IT CAME DOWN TO 300 MG/DL. IN TROUBLESHOOTING, THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WAS NO AIR IN THE TUBING. INSULIN EXITED DURING THE MANUAL PRIME. IT WAS DISCOVERED THAT THE DATE WAS SET TO ONE DAY AHEAD. THE BASAL RATES WERE SET TO ZERO. CUSTOMER WAS ADVISED THIS WAS PROBABLY THE CAUSE OF HER HIGHS. SHE STATED SHE WAS SUPPOSED TO BE ON A PATTERN BASAL. AT THIS POINT, CUSTOMER DISCONNECTED FROM THE CALL. SHE COULD NOT BE REACHED BACK. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682599 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention