BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 2211713 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04353
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    November 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. THE INVESTIGATION CONCLUDED NEITHER AN INSTRUMENT NOR AN ASSAY PROBLEM WAS LIKELY. CALIBRATION WAS ACCEPTABLE AT THE TIME OF THE EVENT. NO ISSUES WITH SAMPLE PREPARATION WERE IDENTIFIED. BASED UPON INFORMATION PROVIDED FOR INVESTIGATION, THE CUSTOMER DID NOT USE THE RECOMMENDED RACK ADAPTORS FOR THE 13MM SAMPLE TUBES. THIS MAY BE A POSSIBLE CAUSE FOR THE EVENT. ANOTHER POSSIBLE ISSUE MIGHT HAVE BEEN BUBBLES ON THE SAMPLE SURFACE. A SPECIFIC REASON FOR THE LOW RESULTS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HUMAN CHORIONIC GONADOTROPIN II (HCG) RESULTS FOR ONE PATIENT. THE SAMPLE WAS REPEATED ON THIS COBAS E411 RACK (E411) ANALYZER AND ON A COBAS 6000 E601 ANALYZER (E601), SERIAL NUMBER (B)(4). THIS ANALYZER USED HUMAN CHORIONIC GONADOTROPIN II REAGENT (HCG), LOT NUMBER 16015101. THE COBAS E601 ANALYZER USED INTACT HUMAN CHORIONIC GONADOTROPIN PLUS BETA REAGENT (B-HCG). THE ORIGINAL B-HCG RESULT WAS 0.435 MIU/ML WHEN TESTED ON THE E601 ANALYZER AND WAS REPORTED TO THE EMERGENCY ROOM. THE EMERGENCY ROOM QUESTIONED THE RESULT BECAUSE THEY COULD HEAR THE BABY'S HEARTBEAT. THE ORIGINAL SAMPLE WAS REPEATED AND A SECOND SAMPLE WAS ALSO DRAWN. THE ORIGINAL SAMPLE WAS INITIALLY REPEATED ON THE E411 ANALYZER AND RECOVERED 2.61 MIU/ML. THE ORIGINAL SAMPLE WAS REPEATED AGAIN ON BOTH THE E601 ANALYZER AND E411 ANALYZERS AND RECOVERED >10000 MIU/ML (ACCOMPANIED BY A DATA FLAG) BOTH TIMES. THE ORIGINAL SAMPLE WAS DILUTED 1:100 AND WAS AGAIN REPEATED ON BOTH THE E601 AND E411 ANALYZERS: THE E601 ANALYZER RECOVERED 118781 MIU/ML (ACCOMPANIED BY A DATA FLAG). THE E411 ANALYZER RECOVERED 126268 MIU/ML (ACCOMPANIED BY A DATA FLAG). THE REDRAW SAMPLE (SAMPLE 2) WAS INITIALLY TESTED ON THE E601 ANALYZER AND GENERATED 10000 MIU/ML (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS DILUTED (1:100) AND RECOVERED 111902 MIU/ML (ACCOMPANIED BY A DATA FLAG). SAMPLE 2, WAS REPEATED ON THE E411 ANALYZER AND RECOVERED 10000 MIU/M (ACCOMPANIED BY A DATA FLAG). IT WAS THEN DILUTED 1:100 AND RECOVERED 122897 MIU/ML (ACCOMPANIED BY A DATA FLAG). ALL THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE CUSTOMER REFUSED A FIELD SERVICE DISPATCH. THE INVESTIGATION IS ON-GOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR TEGRETOL TABLET| DEMULEN| LIPITOR| PAXIL TABLET| T-STAT 2% PADS