BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4132160 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30987
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, PRIME AND DISPLACEMENT TESTS. UNIT RECEIVED WITH STUCK MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. UNIT HAD CRACKED DISPLAY WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNER, RESERVOIR TUBE, RESERVOIR TUBE WINDOW, RESERVOIR TUBE LIP, BELT CLIP SLOT, BATTERY TUBE THREADS, STAINED ADDRESS AND SERIAL NUMBER LABEL AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING RECENT HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING SHOWED THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612481 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522WWP

    Patients

    Seq Age Sex Outcome Treatment
    1