BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1700006 · Received May 27, 2010

    Report

    Report Number
    1823260-2010-03144
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER STATED THEY HAD CREATININE RESULTS FOR SEVERAL PATIENT SAMPLES THAT RECOVERED HIGH ON THE COBAS 6000 ANALYZER (B) (4). WHEN REPEATED ON THE SITE'S SECOND COBAS 6000 ANALYZER (B) (4), THE RESULTS DID NOT MATCH THE ORIGINAL. OF THE DATA PROVIDED, THE RESULTS FOR 6 SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. SAMPLE 1 INITIAL RESULT WAS 11.5, REPEAT RESULT WAS 0.8. SAMPLE 2, FEMALE, (B) (6), INITIAL RESULT WAS 9.7, REPEAT RESULT WAS 0.67. SAMPLE 3, FEMALE, (B) (6), INITIAL RESULT WAS 9.1, REPEAT RESULT WAS 0.59. SAMPLE 4, FEMALE, (B) (6), INITIAL RESULT WAS 10.4, REPEAT RESULT WAS 0.8. SAMPLE 5, FEMALE, (B) (6), INITIAL RESULT WAS 12.8, REPEAT RESULT WAS 0.9. SAMPLE 6 INITIAL RESULT WAS 13.5, REPEAT RESULT WAS 0.97. THE ERRONEOUS RESULTS WERE REPORTED. THE USER STATED THEY DID NOT HAVE INFORMATION CONCERNING WHETHER THE PATIENTS INVOLVED WERE ADMITTED TO THE HOSPITAL, RECEIVED TREATMENT, HAD TREATMENT ALTERED OR WITHHELD, OR SUFFERED ANY EFFECTS AS A RESULT OF THE ERRONEOUS RESULTS. THE REAGENT LOT NUMBER WAS 61901301. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS AN INTERMITTENT VALVE FAILURE. HE REPLACED THE AV2 VALVE ASSEMBLY AND OPTIMIZED THE SYSTEM. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROLS, VERIFIED PATIENT REPRODUCIBILITY AND ALL CHECKS PASSED IN ACCORDANCE WITH THEIR ESTABLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JFY ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR