BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2891785 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-91663
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING SELF TEST DUE TO FAULTY CONNECTOR ON RADIO FREQUENCY BOARD. UNABLE TO COMMUNICATE WITH BLOOD GLUCOSE METER DUE TO ALARM. PROGRAMMED SEVERAL UNITS TO BE DELIVERED AND UNITS WERE DELIVERED PROPERLY. NO UNEXPECTED DELIVERY ANOMALY NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED. THE BLOOD GLUCOSE READING WAS 77MG/DL. THE CUSTOMER STATED THAT A TEMPORARY BASAL NOT PROGRAMMED BEFORE THE ALARM OCCURRED. THE CALLER MENTIONED THAT THE INSULIN PUMP GAVE HER 38.0 UNITS INSTEAD OF 3.8 UNITS, AND IT HAPPENED TWICE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 60 YR