BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1864391 · Received October 12, 2010

    Report

    Report Number
    1823260-2010-06062
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 14, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. CALIBRATION AND QUALITY CONTROLS AT THE TIME OF THE EVENT WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. ALL TESTS WERE WITHIN SPECIFICATION. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR PHENOBARBITAL (PHNO) AND PHENYTOIN (PHNY) ON THE ANALYTICAL P MODULE FOR TWO DIFFERENT SAMPLES COLLECTED FROM THE SAME PATIENT. ALL RESULTS REPORTED IN UG/ML. PATIENT 1, SAMPLE 1. THE ORIGINAL PHNO RESULT WAS 140.10. THE ORIGINAL PHNY RESULT WAS 142.73. BOTH RESULTS WERE ACCOMPANIED BY DATA FLAGS AND WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED WITH DILUTION WHICH YIELDED A PHNO RESULT OF 233.5 AND A PHNY RESULT OF 179.04. THESE RESULTS WERE ACCOMPANIED BY DATA FLAGS. ON (B)(6) 2010, THE USER REPEATED THE SAMPLE A THIRD TIME WITHOUT DILUTION WHICH YIELDED A PHNO RESULT OF 17.11 AND A PHNY RESULT OF 22.14. PATIENT 1, SAMPLE 2. THE ORIGINAL PHNO RESULT WAS 142.34. THE ORIGINAL PHNY RESULT WAS 130.24. BOTH RESULTS WERE ACCOMPANIED BY DATA FLAGS AND WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED WITH DILUTION WHICH YIELDED A PHNO RESULT OF 235.96 AND A PHNY RESULT OF 174.24. THESE RESULTS WERE ACCOMPANIED BY DATA FLAGS. ON (B)(6) 2010, THE USER REPEATED THE SAMPLE A THIRD TIME WITHOUT DILUTION WHICH YIELDED A PHNO RESULT OF 17.44 AND A PHNY RESULT OF 21.90. THE USER COLLECTED A THIRD SAMPLE FROM THE PATIENT ON (B)(6) 2010 FOR FINAL RESULT COMPARISON FOR PHNO AND PHNY. THIS SAMPLE YIELDED A PHNO RESULT OF 18.22 AND A PHNY RESULT OF 20.42. THE USER SAID THE PHNO AND PHNY RESULTS FROM THE THIRD REPEATS FOR SAMPLES 1 AND 2, ALONG WITH THE RESULTS FROM THE THIRD SAMPLE WERE CONSISTENT WITH THE PATIENT'S DIAGNOSIS. THE REPEAT PHNO RESULT OF 17.11 AND PHNY RESULT OF 22.14 FROM SAMPLE 1 AND THE REPEAT PHNO RESULT OF 17.44 AND PHNY RESULT OF 21.90 FROM SAMPLE 2 WERE USED AS THE CORRECTED RESULTS FOR THIS PATIENT. THE USER SAID THERE WAS NO CHANGE IN PATIENT TREATMENT OR HARM TO THE PATIENT AS A RESULT OF THIS EVENT. THE REAGENT LOT NUMBER FOR PHNO WAS 14455800. THE REAGENT LOT NUMBER FOR PHNY WAS 14459200. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS THE R2 AND SAMPLE WASH STATIONS OVERFLOWING. HE REMOVED A CLOT FROM THE SAMPLE WASTE LINE AND A SCREW FROM INSIDE THE R2 WASH STATION. PERFORMANCE TESTS WERE RUN WHICH WERE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW HCG (HUMAN CHORIONIC GONADOTROPIN) RESULTS FOR A PROFICIENCY SURVEY AND SENT PREVIOUSLY TESTED SAMPLES FROM 7 PATIENTS TO ANOTHER LABORATORY FOR REPEAT TESTING. OF THE DATA PROVIDED, THE RESULTS FROM ONE PATIENT SAMPLE WERE DISCREPANT. THE ORIGINAL RESULT WAS 14 MIU/ML WHICH HAD BEEN REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS 37.18 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG REAGENT LOT NUMBER WAS 15653702. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE CHECKED THE MIXER SPEED AND THE OVERALL OPERATION WITH NO ISSUES. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTS WITH ALL RESULTS WITHIN LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1