BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3162640 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03502
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS NOT SUSPECTED. THE ISSUE WITH THE SIPPER WASH STATION FOUND BY THE FIELD SERVICE REPRESENTATIVE WAS DETERMINED TO BE A LIKELY CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULTS FOR SEVEN PATIENT SAMPLES DRAWN AT A FERTILITY CLINIC. ALL RESULTS ARE IN IU/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 40 AND THE REPEAT RESULT WAS <1. PATIENT SAMPLE 2 INITIAL RESULT WAS 15 AND THE REPEAT RESULT WAS <1. PATIENT SAMPLE 3 INITIAL RESULT WAS 9 AND THE REPEAT RESULT WAS 2. PATIENT SAMPLE 4 INITIAL RESULT WAS 12 AND THE REPEAT RESULT WAS 1. PATIENT SAMPLE 5 INITIAL RESULT WAS 45 AND THE REPEAT RESULT WAS <1. PATIENT SAMPLE 6 INITIAL RESULT WAS 5 AND THE REPEAT RESULT WAS 1. PATIENT SAMPLE 7 INITIAL RESULT WAS 12 AND THE REPEAT RESULT WAS <1. NONE OF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE HCG+SS REAGENT LOT NUMBER WAS 17160105 WITH AN EXPIRATION DATE OF 06/30/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND WAS UNABLE TO DUPLICATE THE PROBLEM. HE EXAMINED THE FLUIDICS SYSTEM AND FOUND THE SIPPER WASH STATION HAD REDUCED WASH OUTPUT. HE REPLACED THE SIPPER PROBE WASH STATION, S/R PROBE SYRINGE SEAL, AND PINCH VALVE TUBING. HE PERFORMED ALL SYSTEM SOFTWARE ADJUSTMENT. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE CHECKS WHICH RECOVERED WITHIN SPECIFICATIONS. THE CUSTOMER RAN QC WHICH RECOVERED WITHIN DEFINED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262936 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1