BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3900903 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-86301
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    October 13, 2013
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND RESERVOIR TUBE, SCRATCHED SCREEN AND BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT REWINDING AT ALL, BUT HE DID NOT GET ANY ERROR MESSAGE. THE BLOOD GLUCOSE READING WAS 200MG/DL. THE CALLER ALSO MENTIONED THAT THE DEVICE WAS STUCK ON THE REWIND/BOLUS DELIVERY LOOP. ASSISTED THE CUSTOMER REWINDING/FILLING TUBING PROCESS AND WAS COMPLETED THE PROCESS SUCCESSFULLY. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376962 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR