BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3150891 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-94473
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS NOTED. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP RECEIVED WITH MISSING END CAP STICKER. THE INSULIN PUMP RECEIVED WITH ALL BUTTONS RESPONDING PROPERLY. HOWEVER, MOISTURE TRACES WERE FOUND AT KEYPAD TRACES.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE MANUAL PRIME PROCESS. THE CALLER STATED THAT SHE GOT SICK AND ENDED IN THE HOSPITAL WITH HIGH BLOOD GLUCOSE OF 508MG/DL. THE CUSTOMER EXPERIENCED NAUSEA, STOMACH PAIN, KETONES, AND FREQUENT URINATION. THE CALLER IS (B)(6) PREGNANT. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CUSTOMER HAD AN MRI LAST MONTH, AND SHE WAS DISCONNECTED FROM HIS BODY BUT HAD THE DEVICE CLIPPED TO WAIST UNDER A PROTECTIVE COAT. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249748 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization