BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2891786 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-91668
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH DETACHED END CAP. UNABLE TO TEST FOR MOTOR ERROR ALARMS DUE TO DETACHED END CAP. MOISTURE DAMAGE FOUND ON ELECTRONICS ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 138MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE BACK END OF HER INSULIN PUMP WAS PUSHED OFF BY THE MOTOR, AND IT DID APPEAR THAT THE MOTOR WAS MOVING INTO THE WRONG DIRECTION. THE CALLER STATED THAT SHE ATTEMPTED TO HOLD THE BACK OF THE DEVICE AND TO PRIME, BUT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER IS NINE WEEKS PREGNANT. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR