BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3981383 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06077
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD A BUTTON ERROR ALARM DUE TO FLATTENED ACT BUTTON DOME SWITCH. INSULIN PUMP PASSED THE PRIME AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARM NOTED. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND SEVERE SCRATCHES ON DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. HE ALSO STATED THAT THE INSULIN PUMP HAD PHYSICAL DAMAGE AND THAT THERE WERE SCRATCHES ON THE SCREEN THAT MADE IT DIFFICULT TO READ. HE STATED THAT WHEN HE WAS REFILLING THE INSULIN PUMP, THE BUTTON GOT STUCK AND THAT IS WHEN HE RECEIVED THE BUTTON ERROR ALARM. THE BLOOD GLUCOSE READING WAS NOT KNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458320 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR