BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4090458 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23143
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 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

    (B)(4).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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED FOR 24 HOURS WITH MULTIPLE BASAL RATES, NO BLANK DISPLAY, DISPLAY ANOMALY OR UNEXPECTED RESTART NOTED. ALL OPERATING CURRENTS ARE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARM NOTED. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS. NO DAMAGE INSIDE PUMP NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP SHUT OFF AND STOPPED WORKING. IT WAS STATED THAT THE SCREEN IS COMPLETELY BLANK AND THERE WERE NO ALARMS PRIOR TO IT SHUTTING OFF. BLOOD GLUCOSE VALUE IS 14 MMOL/L. THE DEVICE WAS NOT RECENTLY DROPPED, BUMPED OR EXPOSED TO MOISTURE. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED AND THE BATTERY COMPARTMENT IS NEITHER DAMAGED OR CORRODED. CUSTOMER WAS ADVISED TO INSERT A NEW BATTERY; THE DISPLAY DID NOT RETURN. THEN REMOVED BATTERY FOR 10 MINUTES AND CLEAN BATTERY CAP; THE DISPLAY DID NOT RETURN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570283 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554CMS

    Patients

    Seq Age Sex Outcome Treatment
    1