BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4033346 · Received August 25, 2014

    Report

    Report Number
    2032227-2014-10063
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. INSULIN PUMP WAS UNABLE TO CONFIRM UNEXPECTED BATTERY OUT LIMIT ALARMS DUE TO KEYPAD ANOMALY. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BELT CLIP SLOT AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED FOR A BUTTON ERROR. THE BATTERY WAS CHANGED AND THEN THE INSULIN PUMP ALARMED FOR BATTERY OUT LIMIT. NEITHER ALARM COULD BE CLEARED. THE BLOOD GLUCOSE READING WAS 12.0 MMOL/L. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512346 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAL

    Patients

    Seq Age Sex Outcome Treatment
    1