BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4240590 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49764
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH A CRACKED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND A SHIFTED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A MOTOR ERROR ALARM DURING THE FILL TUBING PROCESS. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARM. BLOOD GLUCOSE LEVEL WAS 280 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723996 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR