BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4242732 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50172
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE VIBRATE CHECK ON THE SELF TEST. THE INSULIN PUMP ALSO VIBRATED PROPERLY WHEN USING THE EASY BOLUS FEATURE. NO VIBRATION ANOMALY WAS NOTED. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER'S INSULIN PUMP DOES NOT VIBRATE WHEN RECEIVING AN ALARM. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THE VIBRATION MODE IS TURNED ON BUT THE PUMP WILL NOT VIBRATE AND WANTS THE INSULIN PUMP TO BE REPLACED. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS. A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725491 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1