BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1982805 · Received February 9, 2011

    Report

    Report Number
    1823260-2011-00732
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 12, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. CALIBRATIONS AND QUALITY CONTROLS WERE WITHIN EXPECTATIONS. AN INSTRUMENT ISSUE WAS NOT IDENTIFIED. IT WAS NOTED THE CUSTOMER IS NOT USING RECOMMENDED RACK ADAPTERS. THIS COULD BE A POSSIBLE CAUSE FOR THE EVENT. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (BETA HCG) RESULTS FOR TWO PATIENT SAMPLES DURING TWO DIFFERENT DAYS. ALL REPEAT TESTING WAS PERFORMED ON THE SAME COBAS 6000 E601 ANALYZER. PATIENT 1, INITIAL RESULT WAS <0.1 MIU/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED AND RECOVERED >10,000 MIU/ML. THE SAMPLE WAS DILUTED AND REPEATED AGAIN, IT RECOVERED 15,052 MIU/ML. PATIENT 2, TESTED (B)(6) 2011, INITIAL RESULT WAS 0.309 MIU.ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED AND RECOVERED 522 MIU/ML. THE CUSTOMER ALSO TESTED ANOTHER TUBE OF BLOOD DRAWN AT THE SAME TIME AND RECOVERED 541 MIU/ML. THE CUSTOMER DID NOT BELIEVE THAT EITHER PATIENT WAS TREATED BASED ON THE INITIAL RESULTS BECAUSE PREVIOUS PATIENT BETA HCG RESULTS FOR BOTH PATIENTS WERE POSITIVE AND THE PHYSICANS QUESTIONED THE INITIAL RESULTS. THE BETA HCG REAGENT LOT NUMBERS WERE 15851502 AND 16015003. THE FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE ISSUE AND DID NOT DETERMINE THE CAUSE. HE PERFORMED DIAGNOSTICS AND A PRECISION STUDY WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1