BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3163690 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-94655
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 26, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE OCCLUSION TEST AND ALARMED DURING THE PRIME TEST AS A RESULT OF MOISTURE DAMAGE INSIDE THE FORCE SENSOR. THE MOTOR PASSED THE MOTOR TEST. THE DEVICE HAD MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR WHILE ATTEMPTING TO BOLUS. THE BLOOD GLUCOSE READING WAS 417MG/DL. THE CALLER STATED THAT SHE DOES NOT HAVE A BACK UP PLAN AND IS OUT OF TOWN, BUT HER HUSBAND WILL TAKE TO THE EMERGENCY ROOM. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264307 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization