BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3940900 · Received July 17, 2014

    Report

    Report Number
    1823260-2014-05295
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED A SERUM SAMPLE AND PLASMA SAMPLE FROM THE PATIENT FOR INVESTIGATION. THE SAMPLES WERE TESTED WITH RETENTION KITS. THE CUSTOMER'S RESULTS WERE REPRODUCED.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATIONS HAVE DETERMINED THAT IN THE ABSENCE OF ONE ASSAY ANTIBODY, NO TNI IS DETECTED IN THE COMPLAINT SAMPLE. THIS SHOWS THAT THE VALUE OBTAINED WITH THE COMPLETE TEST KIT IS FALSE POSITIVE. ACCORDING TO SERUM FRACTIONATION THE PRESENCE OF A HIGH-MOLECULAR WEIGHT INTERFERING FACTOR IS PROBABLE. THUS, THE PRESENCE IN THE COMPLAINT SAMPLE OF AN ANTI-IDIOTYPIC ANTIBODY IS VERY LIKELY. THIS INTERFERENCE IS COVERED BY THE CORRESPONDING STANDARD DISCLAIMER IN THE PACKAGE INSERT. DUE TO LACK OF FURTHER SAMPLE, NO ADDITIONAL INVESTIGATIONS ARE POSSIBLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR TROPONIN I STAT (SHORT TURN AROUND TIME). THE SAMPLE WAS DRAWN IN BOTH A SERUM TUBE AND A PLASMA TUBE. THE PLASMA TUBE WAS INITIALLY TESTED AND RESULTED AS 23.27 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SERUM TUBE WAS THEN USED TO REPEAT TESTING ON AN E2010 DISK ANALYZER AND THIS RESULT WAS 17.80 NG/ML. THE 17.80 NG/ML VALUE WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR WAS NOTIFIED OF THE INITIAL HIGH VALUE AND DIRECTED THE PATIENT TO GO TO ANOTHER FACILITY'S EMERGENCY ROOM FOR FURTHER TESTING. THE RESULT AT THE OTHER FACILITY FROM A SIEMENS CENTAUR ANALYZER "NEGATIVE". THE CUSTOMER BELIEVED THE RESULT FROM THE OTHER SITE TO BE CORRECT. THE PATIENT CONTACTED THE CUSTOMER SITE TO COMPLAIN ABOUT THE RESULTS AS BOTH THE PATIENT AND THE STAFF AT THE CUSTOMER SITE BELIEVED THE RESULTS FROM THE OTHER SITE TO BE CORRECT. THE CUSTOMER SITE THEN PULLED AND REPEATED TESTING ON THE PLASMA AND SERUM TUBES ON (B)(6) 2014. THE PLASMA TUBE WAS REPEATED ON THE E601 ANALYZER AND RESULTED AS 38.52 NG/ML. THE PLASMA TUBE SAMPLE WAS THEN DILUTED 1:2 AND REPEATED ON THE E601 ANALYZER, RESULTING AS 36.56 NG/ML. THE PLASMA TUBE SAMPLE WAS DILUTED 1:4 AND REPEATED ON THE E601 ANALYZER, RESULTING AS 38.0 NG/ML. THE PLASMA TUBE SAMPLE WAS RUN ON THE E2010 ANALYZER, RESULTING AS 19.89 NG/ML. THE PLASMA TUBE SAMPLE WAS DILUTED 1:2 AND REPEATED ON THE E2010 ANALYZER, RESULTING AS 22.08 NG/ML. THE PLASMA TUBE SAMPLE WAS DILUTED 1:4 AND REPEATED ON THE E2010 ANALYZER, RESULTING AS 22.40 NG/ML. THE SERUM TUBE WAS REPEATED ON THE E601 ANALYZER AND RESULTED AS 42.04 NG/ML. THE SERUM TUBE SAMPLE WAS THEN DILUTED 1:2 AND REPEATED ON THE E601 ANALYZER, RESULTING AS 32.48 NG/ML. THE SERUM TUBE SAMPLE WAS DILUTED 1:4 AND REPEATED ON THE E601 ANALYZER, RESULTING AS 35.24 NG/ML. THE SERUM TUBE SAMPLE WAS RUN ON THE E2010 ANALYZER, RESULTING AS 21.21 NG/ML. THE SERUM TUBE SAMPLE WAS DILUTED 1:2 AND REPEATED ON THE E2010 ANALYZER, RESULTING AS 22.02 NG/ML. THE SERUM TUBE SAMPLE WAS DILUTED 1:4 AND REPEATED ON THE E2010 ANALYZER, RESULTING AS 23.08 NG/ML. AN ALIQUOT OF THE SERUM TUBE SAMPLE WAS SENT FOR TESTING AT THE OTHER FACILITY ON THE SIEMENS CENTAUR ANALYZER ON (B)(6) 2014. THE SAMPLE RESULTED AS <0.01 NG/ML, WHICH IS A NEGATIVE RESULT. THE PATIENT WAS SENT TO THE ER AT ANOTHER FACILITY BASED ON THE ERRONEOUS RESULT FROM THE INSTRUMENT. THE PATIENT WAS TESTED AT THE OTHER FACILITY ER AND RELEASED. NO TREATMENT WAS PROVIDED TO THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TROPONIN I REAGENT LOT NUMBER WAS 17442401 WITH AN EXPIRATION DATE OF 10/31/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE AND COULD NOT OBSERVE ANY ANOMALIES. HE CHECKED THE INSTRUMENT FUNCTIONALITY. HE RAN PERFORMANCE TESTING AND ALL PARAMETERS EXCEPT ONE WERE WITHIN SPECIFICATION. IT WAS DETERMINED THAT THE MEASUREMENT SYSTEM WAS MISADJUSTED. HE PERFORMED THE "PMT-HVT" MEASURING ADJUSTMENT PROCEDURE AND RAN A BLANK CELL CALIBRATION ON MEASURING CELL 1. THE CUSTOMER VERIFIED THAT CALIBRATIONS AND CONTROLS WERE WITHIN THE CUSTOMER SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420072 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR