BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2973122 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-91248
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS NOT DELIVERING INSULIN. THE CALLER STATED THAT THE CUSTOMER IS IN THE HOSPITAL, AND HE HAD A TRIPLE BYPASS SURGERY. THE WIFE STATED THAT THE INSULIN PUMP WAS TAKEN OFF AND HIS BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. THE CALLER MENTIONED THAT HER SPOUSE HAD HIGH BLOOD GLUCOSE OF 434MG/DL AND GOT ALSO NO DELIVERY ALARMS. ADVISED THE CALLER THAT THE CUSTOMER NEEDS TO CALL BACK SINCE SHE IS NOT LISTED ON HIS ACCOUNT. TROUBLESHOOTING WAS DECLINED AS CUSTOMER REQUESTED HAVING THE DEVICE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76583 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 55 YR Hospitalization