BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2902237 · Received January 8, 2013

    Report

    Report Number
    2032227-2013-00046
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING PRIME TEST DUE TO MOISTURE DAMAGE ON FORCE SENSOR. CORRODED MOTOR ASSEMBLY NOTED DURING VISUAL INSPECTION.

    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

    THE CUSTOMER REPORTED THAT SHE WAS TREATED BY THE PARAMEDICS DURING THE NIGHT DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WENT TO BED WITH A BLOOD GLUCOSE OF 191 MG/DL, AND AT 3:00 AM SHE DROPPED TO 73 MG/DL. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD ALARMED, AND WAS SQUIRTING OUT INSULIN PRIOR TO THE EVENT. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9632 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention