BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAGO: STA-EVOLUTION (IVD)

    MDR report key: 3008486 · Received February 6, 2008

    Report

    Report Number
    8043723-2008-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 25, 2008
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K983460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONTACT OFFICE/AGENT: THE UNITS WERE ADJUSTED WITH CORRECT VALUES GENERATED BY THE HOSPITAL AND ARE PRESENTLY IN USE. THE FURTHER CONDITION WITH RESPECT TO THE TRANSCRIPTION ERROR IS APPARENT. THE HOSPITAL HAS NOT REPORTED ANY FURTHER INCIDENT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    AFTER THE INSTALLATION OF TWO (2) NEW STAGO STA-R EVOLUTION COAGULATION ANALYZERS, (B)(6) HOSPITAL (A MEMBER OF THE (B)(6)) OBSERVED A SALIENT INCREASE IN THE RATE OF ABNORMAL PROTHROMBIN TIMES (PT) REPORTED. ACCORDING TO THE HOSPITAL, THE AMOUNT OF ABNORMAL PT REPORTED INCREASED FROM 50% (WITH 50% NORMAL PT) TO 96% ABNORMAL PT (WITH 4% NORMAL PT). AS A RESULT OF THIS OBSERVATION, THE HOSPITAL CONDUCTED AN INTERNAL INVESTIGATION AND ASCERTAINED THAT A SIGNIFICANT TRANSCRIPTION ERROR WAS PRESENT AS A RESULT OF THE INSTALLATION PROCESS CREATING THE SYSTEM'S PT NORMAL RANGE WHICH WAS CONSEQUENTLY TOO LOW (TRANSCRIPTION ERROR NORMAL RANGE LOWER THAN THE DETERMINED NORMAL RANGE). THE HOSPITAL ALERTED DIAGNOSTICA STAGO ABOUT THE ERROR. THE TRANSCRIPTION ERROR WHICH HAD OCCURRED DURING THE INSTALLATION OF THE UNITS WAS CORROBORATED BY DIAGNOSTICA STAGO PERSONNEL. THE UNITS WERE ADJUSTED WITH CORRECT VALUES GENERATED BY THE HOSPITAL AND ARE PRESENTLY IN USE. TO DATE, DIAGNOSTICA STAGO IS NOT AWARE OF ANY ADVERSE EVENT TO PTS RESULTING AS A CONSEQUENCE OF THE TRANSCRIPTION ERROR THAT HAD OCCURRED DURING THE INITIAL INSTALLATION OF THE INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAGO: STA-EVOLUTION (IVD) JPA: MULTIPURPOSE IN VITRO COAG. STUDIES JPA DIAGNOSTICA STAGO S.A.S. STA-R-EVOLUTION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other