BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4790960 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58540
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, BROKEN BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, BROKEN RESERVOIR TUBE LIP, MISSING END CAP STICKER. THE INSULIN PUMP ALARMED PRIME DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP WAS UNABLE TO VERIFY HISTORY ANOMALY DUE TO PRIME ALARM. THE INSULIN PUMP PASSED DISPLACEMENT TEST.

    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 VIA PHONE CALL THAT SHE HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 520 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 98 MG/DL. CUSTOMER WAS TRYING TO CHANGE INFUSION SET AND THE PUMP WAS SHOOTING INSULIN AND ALARMING. CUSTOMER TREATED WITH AN INJECTION. CUSTOMER WAS ADVISED TO CLEAR THE ALARM AND REMOVE THE RESERVOIR FROM THE PUMP. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WILL BE SENT A LOANER PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334570 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR