BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3011710 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-91968
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING AN URGENT CARE VISIT. THE CUSTOMER STATED THAT THE NIGHT BEFORE HER BLOOD GLUCOSE WAS 479MG/DL, AND SHE GAVE HERSELF A SHOT, BUT HER GLUCOSE LEVEL KEPT GOING UP. THE CUSTOMER STATED THAT SHE WAS VOMITING AND HAD UNEXPLAINED HIGHS AND LOWS IN THE PAST. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BASAL RATES WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND MULTIPLE ALARMS. THE DRIVE SUPPORT CAP APPEARS NORMAL. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CUSTOMER TO REMOVE THE CANNULA AND IT WAS OCCLUDED. THE CALLER STATED THAT HER SITE IS SORE AND IRRITATED. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114658 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization