BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3080114 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-92805
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO MOISTURE DAMAGE INSIDE FORCE SENSOR. THE INSULIN PUMP PASSED NO DELIVERY TEST AND NO EXCESSIVE NO DELIVERY ALARM NOTED. THE INSULIN PUMP HAD A MISSING END CAP STICKER.

    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 HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 440 MG/DL. CUSTOMER STATED THAT HIS BLOOD GLUCOSE DROPPED TO 50 MG/DL WHILE IN THE HOSPITAL. CUSTOMER ALSO STATED THAT HIS INSULIN PUMP WAS CONSTANTLY ALARMING MOTOR ERROR AND NO DELIVERY ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180749 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 22 YR Hospitalization