BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1970189 · Received January 25, 2011

    Report

    Report Number
    1823260-2011-00377
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 7, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED, IT WAS NOTED THE LEVEL OF HUMIDITY IN THE LABORATORY WAS 22% WHICH IS OUTSIDE OF THE STATED ENVIRONMENTAL SPEICFICATION. THE SPECIFICATION FOR HUMIDITY IS 30-85%. THE FALSELY LOW VALUE WAS MOST LIKELY CAUSED BY A PIPETTING ISSUE. LOW HUMIDITY IS A COMMON REASON FOR LIQUID LEVEL DETECTION PROBLEMS, RESULTING IN DISCREPANT PATIENT RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ONGOING ISSUE AND RECEIVED QUESTIONABLE PARATHYROID HORMONE (PTH-INTACT), THYROTROPIN (TSH) AND INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (BETA-HCG) RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS. HE ALSO EXPERIENCED CALIBRATION ERRORS FOR TSH AND BETA- HCG. THE CUSTOMER PROVIDED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES: PATIENT 1, INITIAL PTH-INTACT RESULT WAS 1.20 PG/ML. THE SAMPLE WAS REPEATED THREE TIMES ON THE SAME COBAS 6000 E601 MODULE AND RECOVERED 44.15 PG/ML, 446.2 PG/ML (TESTED ON (B)(6) 2011)AND 493.3 (TESTED ON (B)(6) 2011). THE PTH-INTACT RESULT 44.15 PG/ML WAS REPORTED OUTSIDE THE LABORATORY. A CORRECTED REPORT WAS NOT SENT SINCE THE DOCTOR REQUESTED THE PATIENT BE REDRAWN AFTER RECEIVING THIS RESULT. A NEW PATIENT SAMPLE HAS NOT BEEN COLLECTED. THE CUSTOMER DID NOT BELIEVE THE PATIENT WAS TREATED BASED ON THE ERRONEOUS RESULT AND NO ADVERSE EVENTS WERE REPORTED. PATIENT 2, FEMALE, BORN (B)(6), INITIAL TSH RESULT WAS 0.100 UIU/ML. THE SAMPLE WAS REPEATED TWICE ON THE SAME COBAS 6000 E601 MODULE AND RECOVERED 5.83 UIU/ML AND 5.86 UIU/ML (TESTED ON (B)(6) 2011). ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY FOR THIS PATIENT BECAUSE THE INITIAL TSH RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE PTH-INTACT REAGENT LOT NUMBER WAS 15918402. THE TSH REAGENT LOT NUMBER WAS 15879701. THE FIELD SERVICE REPRESENTATIVE SUSPECTED A SAMPLING OR REAGENT PIPETTING ISSUE. HE ADJUSTED FLUID LEVELS AND CHECKED THE ANALYZER. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTS WHICH WERE IN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR