BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2102616 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81555
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    March 28, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K053177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED DISPLACEMENT TEST. MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR ERROR ALARM OCCURRED DURING REWIND. THE PHYSICIAN STATED THAT HE COULD NOT OPERATE THE INSULIN PUMP. THE PHYSICIAN THEN STATED THAT HE RESTED THE INSULIN PUMP FOR FIVE MINUTES, CHANGED THE BATTERY, AND THAT HE STILL COULD NOT REWIND THE INSULIN PUMP. THE PHYSICIAN FURTHER STATED THAT THE MOTOR ERROR ALARM OCCURRED AGAIN AND REPEATED SEVERAL TIMES. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712EWS

    Patients

    Seq Age Sex Outcome Treatment
    1