BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2946145 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00725
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLB
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. THE DATA PROVIDED BY THE CUSTOMER WAS REVIEWED. THE QC RESULTS INDICATED NO ISSUE. THE ALARM TRACE INDICATED NO ISSUE. IT WAS NOTED THAT THE 10 MINUTE CLOTTING TIME FOR THE SAMPLE WAS TOO SHORT.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED ON FURTHER FOLLOW UP WITH THE CUSTOMER THAT THE INITIAL RESULT WAS 18.62 NG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 18.6, WHICH WAS REPORTED OUT OF THE LABORATORY. AFTER THE RESULT WAS QUESTIONED BY THE PHYSICIAN, THE SAMPLE WAS REPEATED ON THE INITIAL ANALYZER AND GENERATED A "4. SOMETHING". THE SAMPLE WAS THEN REPEATED ON THE OTHER ANALYZER AND GENERATED A RESULT OF 4.0 NG/ML; WHICH WAS REPORTED OUT IN AN AMENDED REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON CK-MB, THE MB ISOENZYME OF CREATININE KINASE (CK-MB) FOR ONE PATIENT SAMPLE. ALL RESULTS ARE IN NG/ML. THE INITIAL RESULT WAS (B)(6) AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS RE-RUN. THE SAMPLE WAS REPEATED ON THIS INSTRUMENT AND GENERATED A RESULT OF "(B)(6) SOMETHING". THE SAMPLE WAS THEN RUN ON ANOTHER COBAS E601 ANALYZER AND GENERATED A RESULT OF (B)(6). THIS RESULT WAS ISSUED AS THE AMENDED RESULT. THE CUSTOMER DID NOT HAVE FURTHER INFORMATION REGARDING THE RESULTS. THERE WAS NO ADVERSE EVENT. THE LOT OF CK-MB REAGENT IN USE WAS 16989801, WITH AN EXPIRATION DATE OF 07/31/2013. THE FIELD SERVICE REPRESENTATIVE DID NOT FIND A CAUSE FOR THE ISSUE. HE CLEANED AND CHECKED THE FLOW PATH AND EXAMINED THE MIXING PADDLE FOR DAMAGE AND MISALIGNMENT. HE PERFORMED DIAGNOSTIC AND MECHANICAL CHECKS, WHICH PASSED. THE CUSTOMER PERFORMED QC, WHICH ALSO PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50502 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JLB ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1