BEUDAMED
    FDA Adverse Event Other Summary report: N

    STA COMPACT

    MDR report key: 2678616 · Received June 13, 2012

    Report

    Report Number
    8043723-2012-00001
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    April 28, 2012
    Report Date
    July 13, 2012
    Manufacturer
    DIAGNOSTICS STAGO SAS
    Product Code
    JPA
    PMA / PMN Number
    K093167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIAGNOSTIC STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTIC STAGO (B)(4) (MFR) UNDER EXEMPTION NUMBER (B)(4). AS SPECIFIED IN THE STA COMPACT REFERENCE MANUAL, (B)(4), THE HANDLING OF ¿CANCELLING A CALIBRATION REQUEST¿ MUST BE UNDERTAKEN WITH UTMOST CAUTION. IN THIS CASE, THE TECHNICIAN CALLED THE US HOT LINE FOR ASSISTANCE IN RECOVERING FROM CANCELLING A CALIBRATION THAT HAD BEEN LAUNCHED. DURING THIS PROCESS, THE LOT SPECIFIC VALUE OF THE INTERNATIONAL SENSITIVITY INDEX (ISI) WAS NOT VERIFIED ¿ ONLY THAT A VALUE WAS PRESENT IN THE FIELD. THE ISI VALUE COULD HAVE EASILY BEEN VERIFIED BY CHECKING EITHER THE LOT SPECIFIC BAR CODE SHEET INCLUDED IN EVERY REAGENT KIT OR BY COMPARISON WITH THE SETTINGS ON THE SECOND ANALYZER, WHICH WAS UNAFFECTED. THE CORRECT ISI VALUE FOR THIS LOT (LN 107323) OF STA NEOPLASTINE CI + REAGENT IS 1.31. THE ISI VALUE HAD DEFAULTED TO 1.00, WHICH RESULTED IN THE UNDERESTIMATION OF SUBSEQUENT RESULTS. DIAGNOSTIC STAGO, INC. (US) IS TAKING THE FOLLOWING ACTIONS TO PREVENT RECURRENCE: AMENDING ITS HOTLINE TROUBLESHOOTING GUIDE TO EMPHASIZE THE NECESSITY OF VERIFYING THE ISI VALUE WHENEVER A CALIBRATION IS CANCELLED, TRAINING THE HOTLINE AGENTS ON THE REVISED TROUBLESHOOTING GUIDE. AMENDING ITS EXTERNAL CUSTOMER TRAINING MATERIALS AND INTERNAL FIELD SERVICE ENGINEER AND TECHNICAL SUPPORT SPECIALIST TRAINING MATERIALS TO EMPHASIZE THE NECESSITY OF VERIFYING THE ISI VALUE WHENEVER A CALIBRATION IS CANCELLED.

    Description of Event or Problem · 1

    THE LAB TECH ERRONEOUSLY ORDERED THE ANALYZER TO RUN A CALIBRATION FOR PT, APTT, AND FIBRINOGEN ASSAYS, THEN CANCELLED THE CALIBRATION DESPITE THE WARNING IN THE INSTRUMENT MANUAL. THE TECH CALLED HOTLINE TECHNICAL SUPPORT FOR ASSISTANCE IN RECOVERING FROM THE CANCELLATION. DURING THIS PROCESS, THE LOT SPECIFIC VALUE OF THE INTERNATIONAL SENSITIVITY INDEX (ISI) WAS NOT VERIFIED. THE CORRECT ISI VALUE IS ONLY REQUIRED FOR THE PT ASSAY. THE CORRECT ISI VALUE FOR THIS LOT OF STA NEOPLASTINE CI + REAGENT, LOT NUMBER 107323, IS 1.31. THE ISI VALUE DEFAULTED TO 1.00 RESULTING IN THE UNDERESTIMATION OF THE INTERNATIONAL NORMALIZED RATIO (INR) VALUE FOR APPROX. 2000 TEST RESULTS GENERATED BETWEEN (B)(6) 2012 WHEN THE ISI VALUE WAS DETERMINED TO BE INCORRECT. THE NUMBER OF SECONDS REPORTED FOR THE PT ASSAY WAS UNAFFECTED, SINCE THIS IS THE PRIMARY MEASUREMENT. 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 801 VALUES WHERE THE DIFFERENCE BETWEEN THE ORIGINAL REPORTED RESULTS AND THE RECALCULATED RESULTS EXCEEDED 10%. CORRECTED REPORTS WERE ISSUED FOR THESE 801 RESULTS. NO INJURIES OR DEATHS HAVE BEEN REPORTED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1