BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1981752 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00691
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LDP
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS THE SAMPLE IN QUESTION WAS NOT AVAILABLE FOR FURTHER TESTING. IT WAS NOTED THE DISCREPANT RESULT OF THE UNDILUTED SECOND PATIENT SAMPLE IS MOST PROBABLY DUE TO THE PRESENCE OF AN INTERFERENT IN THE SAMPLE. AFTER DILUTION OF THE SAMPLE, THE INTEREFERENT WAS DILUTED OUT AS WELL, GIVING A RESULT AS EXPECTED.

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER RECEIVED QUESTIONABLE ACETAMINOPHEN RESULTS FOR ONE PATIENT SAMPLE. THE RESULT FROM THE FIRST SAMPLE DRAWN FROM THE PATIENT WAS 521 UG/ML AFTER MANUAL DILUTION. THE PATIENT WAS DRAWN A SECOND TIME AND THE SAMPLE WAS RUN ON THE MODULAR P ANALYZER SERIAL NUMBER (B)(4) WITH A RESULT OF 18.1 UG/ML WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE TECHNOLOGIST QUESTIONED THE RESULT AND REPEATED TESTING ON THE COBAS C501 SERIAL NUMBER (B)(4) AND THE RESULT WAS 17 UG/ML. THE USER THEN MANUALLY DILUTED THE SAMPLE 1:5 AND TESTED IT ON THE MODULAR P ANALYZER WITH A RESULT OF 244 UG/ML. THE USER ALSO TESTED THE DILUTED SAMPLE ON THE COBAS C501 AND THE RESULT WAS 232.5 UG/ML THE USER CALLED THE DOCTOR WITH THE CORRECTED REPORT AND THE PATIENT WAS NOT TREATED BASED ON THE INCORRECT RESULT. THE ACETAMINOPHEN REAGENT LOT NUMBER WAS NOT PROVIDED. THE USER DECLINED A SERVICE VISIT AND STATED THE RESULTS MATCHED WITH THE MODULAR P ANALYZER AND SHE HAS NOT ANY OTHER ISSUES SO SHE BELIEVES THIS HAS TO DO WITH EITHER THE SAMPLE OR THE ASSAY, NOT A PROBLEM WITH THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 015 YR