BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4210500 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37553
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 HAD A BLANK DISPLAY DUE TO CORRODED BATTERY TUBE AND BATTERY CAP CONTACTS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW. NO TRACES OF MOISTURE WERE NOTED AT THE ELECTRONIC, MOTOR OR KEYPAD ASSEMBLIES PER VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCREEN OF THE INSULIN UMP WENT BLANK AFTER A BATTERY CHANGE. HE ALSO REPORTED RECEIVING A BATTERY OUT LIMIT ALARM. THE BLOOD GLUCOSE READING WAS 360 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. HE STATED THAT THE INSULIN PUMP HAD A MINOR CRACK AND HAD BEEN DROPPED IN THE SINK AND THAT A LITTLE WATER GOT ONTO IT. HE STATED THAT THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED AND THAT THE BATTERY COMPARTMENT WAS NOT DAMAGED OR CORRODED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647418 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR