BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4242832 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-49923
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. THE FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE ALARM. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE, A CRACKED BELT CLIP SLOT, A STAINED END CAP STICKER AND CRACKED BATTERY TUBE THREADS.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE OF 48 MG/DL. THE LOW BLOOD GLUCOSE WAS TREATED WITH JUICE. THE INSULIN PUMP ALARMED AN A-33 ERROR DURING THE MANUAL PRIME PROCESS. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725193 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR