BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5143242 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-55994
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    August 4, 2015
    Report Date
    September 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT DID NOT HAVE A CRACK ON THE LCD GLASS. HOWEVER, THE UNIT HAD A BLEEDING LCD GLASS. THE UNIT ALSO HAD A CRACKED DISPLAY WINDOW, A MINOR SCRATCHED DISPLAY WINDOW, AND CRACKED BATTERY TUBE THREADS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT THE INSULIN PUMP DISPLAY WAS CRACKED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS INFORMED TO RETURN THE PRODUCT FOR ANALYSIS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672983 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1