BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1961555 · Received January 14, 2011

    Report

    Report Number
    1823260-2011-00253
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    May 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. CALIBRATION AND QUALITY CONTROL DATA WERE WITHIN EXPECTATIONS. NO REAGENT ISSUE IS EVIDENT. PERFORMANCE CHECKS WERE WITHIN SPECIFICATION. THERE IS NO INDICATION AN INSTRUMENT ISSUE WAS PRESENT. PREANALYTICAL ISSUES WERE IDENTIFIED AS A POSSIBLE CAUSE OF THE EVENT. IT WAS NOTED THE CUSTOMER WAS CENTRIFUGING SAMPLES FOR 5 MINUTES, WHICH WAS DETERMINED TO BE INSUFFICIENT. IN ADDITION, THE CUSTOMER WAS NOT USING THE RECOMMENDED RACK ADAPTERS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A DISCREPANT RESULT WHEN USING THE INTACT HUMAN CHORIONIC GONADOTROPIN + SS SUBUNIT (HCG+SS) APPLICATION ON THE COBAS 6000 CORE ANALYZER. THE INITIAL HCG+SS RESULT WAS > 10,000 MIU/ML. THE ANALYZER PERFORMED AN AUTODILUTION AND REPEATED THE TEST WITH A RESULT OF 293 MIU/ML. THE CUSTOMER STATED THAT, ALTHOUGH THIS RESULT WAS FLAGGED BY THEIR LIS AS FAILING DELTA CHECK, THE RESULT WAS RELEASED OUTSIDE THE LABORATORY. THE NEXT DAY THE CUSTOMER NOTICED THE DISCREPANCY AND REPEATED THE SAMPLE AGAIN ON THE SAME ANALYZER AND OBTAINED AN HCG+SS OF > 10,000 MIU/ML. THE ANALYZER PERFORMED AN AUTODILUTION AND REPEATED THE TEST WITH A RESULT OF 12923 MIU/ML, WHICH WAS RELEASED AS A CORRECTED RESULT. THE CUSTOMER STATED THE PATIENT WAS NOT TREATED BASED ON THE DISCREPANT RESULT AND THERE WAS NO IMPACT TO THE PATIENT DUE TO THIS EVENT. THE HCG+SS REAGENT LOT NUMBER WAS 15851502. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE CUSTOMER DID STATE TO THE FIELD SERVICE REPRESENTATIVE THAT A REFRIGERATOR HAD FROZEN AND IT APPEARED AT THE TIME THAT SOME REAGENTS MAY HAVE BEEN FROZEN. IT IS UNKNOWN IF THIS OCCURRENCE HAD ANY AFFECT ON THIS EVENT. THE FIELD SERVICE REPRESENTATIVE PERFORMED MAINTENANCE AND SYSTEM CHECKS. ALL MECHANISM CHECKS AND PERFORMANCE TESTS WERE GOOD. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WHICH WERE WITHIN THE CUSTOMER'S SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR