BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3024006 · Received March 27, 2013

    Report

    Report Number
    2032227-2013-01177
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    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.

    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 EXPERIENCED LOW BLOOD GLUCOSE LEVELS, AND PASSED OUT. THE CUSTOMER STATED THAT SHE WORKS AT A HOSPITAL, AND SHE WAS TREATED IMMEDIATELY. THE CUSTOMER DID NOT REMEMBER ANYTHING ELSE. TROUBLESHOOTING WAS PERFORMED, AND WHILE REVIEWING THE CARE LINK REPORTS, IT WAS NOTED THAT THE CUSTOMER DELIVERED A BOLUS AT 5:11 AM TO TREAT A BLOOD GLUCOSE OF 531 MG/DL. LESS THAN AN HOUR LATER, THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS. ADVISED THE CUSTOMER TO TEST THE GLUCOMETER TO ENSURE THAT IT WAS WORKING PROPERLY, BUT SHE DID NOT HAVE THE TESTING SOLUTION. ADVISED HER TO CONTACT THE MANUFACTURER. CONFIRMED THAT THE PROGRAMMING WAS CORRECT ON THE INSULIN PUMP. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. HOWEVER, THE RESERVOIR VOLUME DID NOT MATCH WITH THE AMOUNT OF INSULIN IN THE RESERVOIR. 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
    126303 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization