BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4183114 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40144
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RELAY. THE MOTOR PASSED MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED CASE AT RESERVOIR TUBE WINDOW CORNER.

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. DEVICE WAS NOT EXPOSED TO A MAGNETIC FIELD. CUSTOMER DOES NOT USE THE SENSOR FEATURE AND IS UNABLE TO COMPLETE THE REWIND SEQUENCE. BLOOD GLUCOSE VALUE IS 189 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660090 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAS A000142707

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR