BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3182741 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02516
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION TEST DUE TO PRIME ANOMALY.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THERE IS A PROBLEM WITH THE SUPPLIES OR INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE READING IS 301 MG/DL. CUSTOMER HAS TREATED WITH BOLUS. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. PROGRAMMING IS CORRECT. MANUAL PRIME IS CORRECT, THE INSULIN DID EXIT THE TUBING. HIGH PRESSURE TEST FAILED TWICE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283879 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR