BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233560 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48737
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALARMS WERE NOTED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND MOTOR TEST. HOWEVER, THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE INSULIN PUMP WAS ALSO RECEIVED WITH A CRACKED DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, AND A CRACKED BELT CLIP SLOT.

    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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM DURING BOLUS ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN MG/DL. THE CUSTOMER WAS ADVISED TO RETURN THE INSULIN PUMP WITH BATTERY AND ZERO BASAL RATES. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715246 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1