BEUDAMED
    FDA Adverse Event Other Summary report: N

    STA COMPACT

    MDR report key: 2927799 · Received January 16, 2013

    Report

    Report Number
    8043723-2013-00001
    Event Type
    Other
    Date Received
    January 16, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 15, 2013
    Manufacturer
    DIAGNOSTICA STAGO SAS
    Product Code
    JPA
    PMA / PMN Number
    K093167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIAGNOSTICA STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTICA STAGO (B)(4) (MANUFACTURER) UNDER EXEMPTION NUMBER (B)(4). AS SPECIFIED IN THE STA COMPACT REFERENCE MANUAL, CONDITIONS CONNECTED WITH THE TEST SET UP MAY HAVE CONSEQUENCES ON THE RELIABILITY OF THE RESULTS THEREFORE MUST BE UNDERTAKEN WITH THE UPMOST CAUTION. IN THIS CASE THE LABORATORY TECHNICIAN CALLED THE US HOTLINE ON (B)(6) 2012 BUT THERE WAS NO DISCUSSION OF THE ISI VALUE. THE ISI VALUE SHOULD HAVE BEEN CHECKED DURING THIS CALL. ON THE NEXT CALL FROM THE LABORATORY TECHNICIAN TO THE US HOTLINE FOR ASSISTANCE WITH A CHANGE TO SECURITY ON THE COMPACT; THE DISCUSSIONS LEAD TO THE DISCOVERY OF THE FACT THAT THE LABORATORY TECHNICIAN RAN A CALIBRATION INSTEAD OF QC RESULTING IN THE RESETTING OF THE ISI VALUE DURING THE PROCESS THE LOT SPECIFIC VALUE OF THE INTERNATIONAL SENSITIVITY INDEX (ISI) WAS NOT VERIFIED. THE ISI VALUE COULD HAVE BEEN VERIFIED BY CHECKING THE LOT SPECIFIC BAR CODE SHEET INCLUDED IN EVERY REAGENT KIT. THE CORRECT ISI VALUE FOR THE LOT OF STA NEOPLASTINE CI+ REAGENT LOT NUMBER 108245 IS 1.28. THE ISI VALUE DEFAULTED TO 1.00 WHICH RESULTED IN THE UNDERESTIMATION SUBSEQUENT RESULTS. DIAGNOSTICA STAGO INC. IS TAKING THE FOLLOWING ACTIONS TO PREVENT RECURRENCE: RE-TRAINING OF THE HOTLINE AGENTS. FIELD SERVICE ENGINEERS AND TECHNICAL SUPPORT SPECIALIST TO EMPHASIZE THE NECESSITY OF VERIFYING THE ISI VALUE WITH THE CUSTOMERS.

    Description of Event or Problem · 1

    THE LABORATORY TECHNICIAN CALLED THE HOTLINE TECHNICAL SUPPORT FOR ASSISTANCE TO CHANGE SECURITY ON THE COMPACT. DURING THE DISCUSSION IT WAS REVEALED THAT THE ISI HAD BEEN RESET LAST WEEK TO 1.0 WHEN THE LABORATORY TECHNICIAN ERRONEOUSLY ORDERED THE ANALYZER TO RUN A CALIBRATION INSTEAD OF QC. THE LOT SPECIFIC VALUE OF THE INTERNATIONAL SENSITIVITY INDEX (ISI) WAS RESET. THE ISI VALUE IS ONLY REQUIRED FOR THE PT ASSAY. THE CORRECT ISI VALUE FOR THIS LOT OF STA NEOPLASTINE CI+ REAGENT LOT NUMBER 108245 IS 1.28. THE ISI VALUE DEFAULTED TO 1.00 RESULTING IN THE UNDERESTIMATION OF THE INTERNATIONAL NORMALIZED RATIO (INR) VALUE FOR APPROXIMATELY 327 TEST RESULTS APPROXIMATELY BETWEEN WEEK OF (B)(6) AND WEEK OF (B)(6) 2012 WHEN THE ISI VALUE WAS DETERMINED TO BE INCORRECT. THE INR IS CALCULATED FROM THE PT'S PROTHROMBIN TIME (SECONDS), THE GEOMETRIC MEAN OF THE SITE'S NORMAL RANGE, AND THE ISI VALUE FOR THE ASSAY SYSTEM. THE SITE RECALCULATED THE INR VALUES FOR ALL REPORTED RESULTS AND IDENTIFIED 187 THAT HAD TO BE CORRECTED. THE 140 RESULTS WERE NOT CORRECTED. PROPER NOTIFICATION WAS SUPPLIED FOR INRS >2.0. CORRECTED REPORTS WERE ISSUED FOR THE RESULTS. NO INJURIES OR DEATHS HAVE BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24881 STA COMPACT JPA DIAGNOSTICA STAGO SAS

    Patients

    Seq Age Sex Outcome Treatment
    1