BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1950909 · Received January 6, 2011

    Report

    Report Number
    1823260-2011-00070
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE APPLICATIONS ON THE COBAS C501 ANALYZER. THE EVENT INVOLVED 16 PATIENT SAMPLES. FIVE SAMPLES WERE DISCREPANT FOR C-REACTIVE PROTEIN (CRP), CREATININE PLUS (CREP2), ALBUMIN (ALB) AND/OR CYSTATIN C (CYSC). THE SAMPLES WERE REPEATED ON ANOTHER COBAS INSTRUMENT. PATIENT SAMPLE 1, THE INITIAL CRP RESULT WAS 58.1 MG/L; THE REPEAT RESULT WAS 26.1 MG/L. PATIENT SAMPLE 2, (B)(6) FEMALE, DATE OF BIRTH (B)(6). THE INITIAL CREP2 RESULT WAS 105 UMOL/L; THE REPEAT RESULT WAS 66 UMOL/L. PATIENT SAMPLE 3, (B)(6) FEMALE, DATE OF BIRTH (B)(6). THE INITIAL ALB RESULT WAS 51 G/L; THE REPEAT RESULT WAS 38 G/L. PATIENT SAMPLE 4, (B)(6) MALE, DATE OF BIRTH (B)(6). THE INITIAL CYSC RESULT WAS 0.98 MG/L; THE REPEAT RESULT WAS 1.29 MG/L. PATIENT SAMPLE 5, (B)(6) FEMALE, DATE OF BIRTH (B)(6). THE INITIAL CRP RESULT WAS 253 MG/L; THE REPEAT RESULT WAS 79.2 MG/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. FROM (B)(6) 2010 UNTIL (B)(6) 2010 THE CUSTOMER REPORTED THE REPEAT RESULTS AS CORRECTED REPORTS TO THE MEDICAL DOCTORS FOR THESE PATIENT SAMPLES. THE CORRECTED REPORTS WERE ISSUED BEFORE ANY OF THE PATIENTS WERE WRONGLY TREATED. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THIS EVENT. THE REAGENT LOT NUMBERS FOR CRP, CREP2, ALB AND CYSC WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED RINSE STATION TUBING, RINSE STATION RELATED VALVE AND REAGENT PROBE. NO FURTHER ISSUES HAVE BEEN REPORTED SINCE SERVICE VISIT. AFTER FURTHER INVESTIGATION AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER NQD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 038 YR