BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920045 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86513
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED BY THE CUSTOMER THAT HER INSULIN PUMP WAS ALARMING NO DELIVERY WITH VISIBLE SCRATCHES ON THE DISPLAY SCREEN AND UPON INQUIRING FURTHER, IT WAS DISCOVERED THAT SHE HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) OF 2014. CUSTOMER STATED SHE WAS NOT WEARING HER INSULIN PUMP AT THE TIME OF HOSPITALIZATION. BLOOD GLUCOSE LEVEL WAS 36 MG/DL AT TIME OF HOSPITALIZATION. WHILE TROUBLESHOOTING THE INSULIN PUMP ALARM, CUSTOMER STATED THAT DEVICE HAD BEEN DROPPED ON THE FLOOR AFTER GETTING CAUGHT ON A DOOR HANDLE. CUSTOMER ALSO STATED SHE DOESN'T REMEMBER HOW LONG SHE HAD BEEN OFF THE INSULIN PUMP PRIOR TO THE EMERGENCY ROOM VISIT. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO HEALTHCARE PROVIDER'S INSTRUCTIONS. BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396600 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization