BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3961425 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-88248
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    PUMP UNABLE TO PRIME DURING THE PRIME/A33 TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO A33 ALARM NOTED. UNIT HAD SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNER, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER WAS HAVING ISSUES WITH HIS INSULIN PUMP. HIS BLOOD GLUCOSE IS 9.7 MMOL/L. CUSTOMER'S DEVICE IS ALARMING. HE IS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER ALSO SAID HE LOST HIS BELT CLIP, SO THE DEVICE WAS DROPPED ONCE PRIOR TO THE ALARM. THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. HE WAS ADVISED THE POSSIBLE CAUSE OF THE ALARM WAS THAT DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437397 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1