BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAGO: STA - COMPACT (IVD)

    MDR report key: 2598393 · Received August 28, 2009

    Report

    Report Number
    8043723-2009-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2009
    Date of Event
    June 28, 2009
    Report Date
    July 28, 2009
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K961579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACT OFFICE/AGENT: THE UNIT WAS ADJUSTED WITH CORRECT ISI VALUE AND IS PRESENTLY IN USE. NO FURTHER CONDITION WITH RESPECT TO THE INCORRECT ISI VALUE IS APPARENT. THE HOSPITAL HAS NOT REPORTED ANY FURTHER INCIDENT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER (USER), VETERANS ADMINISTRATION MEDICAL CENTER - (B)(4), CONTACTED DIAGNOSTICA STAGO (DSI) REGARDING THE USAGE OF AN INSTRUMENT WITH THE INCORRECT ISI VALUE. THIS WAS ATTRIBUTED TO THE FACT THAT THE CUSTOMER ERRONEOUSLY ORDERED CALIBRATION FOR THE PROTHROMBIN TIME ASSAY VERSUS THE QC. SUBSEQUENTLY, THE CUSTOMER WAS ADVISED TO CANCEL THE CALIBRATION AND RESTORE THE PREVIOUS CURVE. TO ACCOMPLISH THIS, THE REFERENCE TIME HAD TO BE RE-ENTERED BUT THE ISI WAS NOT CHANGED, BUT INSTEAD, THE SYSTEM ENTERED THE DEFAULT ISI VALUE = 1.00. FOLLOWING THIS INCIDENT, THE ISI VALUE WAS RETURNED TO THE CORRECT VALUE AND TESTING CONTINUED. REVIEW BY THE CUSTOMER REVEALED THAT SEVERAL HUNDRED PTS WERE EXPOSED TO TESTING UTILIZING THE INCORRECT ISI VALUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO INCORRECT THERAPY. FURTHER INVESTIGATION BY (B)(4) DETERMINED THAT ONLY ONE (1) PT'S THERAPY WAS IMPACTED WHICH ACCOUNTED FOR THE PT MISSING ONE (1) TREATMENT CYCLE. THE THERAPY FOR THIS PT IMMEDIATELY RESUMED AS INTENDED. AS OF THIS DATE, DSI IS NOT AWARE OF ANY ADD'L PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other