BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3233277 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-95793
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    THE INSULIN PUMP UNABLE TO PRIME DURING THE PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM THE EXCESSIVE NO DELIVERY ALARM DUE TO PRIME ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT GIVING HER THE CORRECT DOSAGE OF INSULIN. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 219MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE ALARM HISTORY REVEALED A NO DELIVERY ALARM. THE CALLER STATED WHILE ATTEMPTING TO REWIND THE PISTON DID STOP, AND THE CUSTOMER KEPT REWINDING THE PISTON DOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335684 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 11 YR