BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183113 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40143
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, LCD WINDOW, RESERVOIR TUBE WINDOW AND CASE AT RESERVOIR TUBE WINDOW CORNERS, MINOR SCRATCHES ON LCD WINDOW CASE AND RESERVOIR TUBE WINDOW.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WAS GETTING IN THE CAR AND HIS BELT CLIP BROKE; THE INSULIN PUMP FELL AND THE SCREEN AND RESERVOIR COMPARTMENT BROKE. CUSTOMER STATED THAT THE LCD SCREEN AND THE RESERVOIR COMPARTMENT ARE CRACKED. BLOOD GLUCOSE VALUE IS 113 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661162 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR