BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3092464 · Received May 3, 2013

    Report

    Report Number
    1823260-2013-02746
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ELEVEN PATIENTS, NINE OF WHICH HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. ALL TESTING WAS PERFORMED ON THE SAME ANALYZER. THE SAMPLES WERE REPEATED ON (B)(6) 2013. THE SAMPLES WERE AGAIN REPEATED ON (B)(6) 2013 AFTER PUTTING A NEW REAGENT PACK FROM THE SAME LOT AS THE ORIGINAL REAGENT PACK ONTO THE ANALYZER AND RUNNING QUALITY CONTROL. THE SAMPLES WERE THEN REPEATED ON (B)(6) 2013 WITH THE NEW REGENT PACK AFTER THE FIELD SERVICE REPRESENTATIVE EXCHANGED THE PINCH TUBE ON THE ANALYZER. PATIENT ONE'S FIRST RESULT WAS 96.01 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL REAGENT PACK WAS <0.100 MIU/ML. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. PATIENT TWO, A (B)(6) FEMALE, HAD A FIRST RESULT OF 27.92 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL REAGENT PACK WAS <0.100 MIU/ML. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. PATIENT THREE, A (B)(6) FEMALE, HAD A FIRST RESULT OF 25.65 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL REAGENT PACK WAS <0.100 MIU/ML. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. PATIENT FOUR, A (B)(6) FEMALE, HAD A FIRST RESULT OF 80.07 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL REAGENT PACK WAS 176.0 MIU/ML. THE SAMPLE WAS REPEATED AGAIN ON THE ORIGINAL REAGENT PACK AND THE RESULT WAS <0.100 MIU/ML. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. PATIENT FIVE, A (B)(6) FEMALE, HAD A FIRST RESULT OF 176.01 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL REAGENT PACK WAS <0.100 MIU/ML. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. PATIENT SIX, A (B)(6) FEMALE, HAD A FIRST RESULT OF 3.56 MIU/ML. THE SAMPLE WAS NOT REPEATED ON THE ORIGINAL REAGENT PACK. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. PATIENT SEVEN, A (B)(6) FEMALE, HAD A FIRST RESULT OF 9562 MIU/ML. THE SAMPLE WAS NOT REPEATED ON THE ORIGINAL REAGENT PACK. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS >10000 MIU/ML. THE SAMPLE WAS DILUTED 1:100, AND THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS 13729 MIU/ML. PATIENT EIGHT, A (B)(6) FEMALE, HAD A FIRST RESULT OF 840.20 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL REAGENT PACK WAS <0.100 MIU/ML. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS <0.100 MIU/ML. PATIENT NINE, A (B)(6) FEMALE, HAD A FIRST RESULT OF 630.1 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL REAGENT PACK WAS 95.06 MIU/ML. THE FIRST RESULT FROM THE NEW REAGENT PACK WAS 96.84 MIU/ML. THE REPEAT RESULT FROM THE NEW REAGENT PACK WAS 97.14 MIU/ML. THE REPEAT RESULTS FROM THE NEW REAGENT PACK WERE ISSUED AS CORRECTED REPORTS. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 169563 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ON SITE. HE REPLACED THE PINCH TUBE. HE VISUALLY CHECKED THE REAGENT FOR BUBBLES, FOAM, OR BEADS ON THE CAP, BUT NOTHING ABNORMAL WAS DETECTED. FOR MOST PATIENTS, THEIR RESULTS WERE REPRODUCIBLE. THE FSR REPEATED SOME SAMPLES RUN ON (B)(4) 2013 AFTER THE PINCH TUBE WAS EXCHANGED, AND ALL THE RESULTS WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193683 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 016 YR PATIENT ONE GESTINOL-28| PATIENT EIGHT CERAZETE