BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974634 · Received August 3, 2014

    Report

    Report Number
    3004209178-2014-89230
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP WAS NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP ALARMED DURING THE REWIND DUE TO A CORRODED MOTOR HOME SWITCH. THE MOTOR ERROR ALARM COULD NOT BE CONFIRMED DUE TO THIS ALARM. HOWEVER, THE INSULIN PUMP PASSED THE DISPLACEMENT TEST.

    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 RECEIVING A MOTOR ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP WOULD NOT REWIND. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 347 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452379 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR