BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2987297 · Received March 4, 2013

    Report

    Report Number
    1823260-2013-01265
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED 20 RESULTS FOR HUMAN CHORIONIC GONADOTROPIN, SHORT TURN AROUND TIME (HCG STAT). OF THOSE 20 RESULTS, FOUR WERE FOUND TO BE ERRONEOUS. ALL RESULTS ARE IN MIU/ML, AND ALL PATIENTS ARE PREGNANT FEMALES. ON (B)(6) 2013, A DOCTOR QUESTIONED A NEGATIVE RESULT THAT WAS REPORTED FOR PATIENT 1. ON REPEAT, IT THE SAMPLE WAS IN THE 90,000 RANGE. THERE WAS NO ADVERSE EVENT. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2013, PATIENT 2 WAS RESULTED ON E601 SERIAL NUMBER (B)(4) AS 0.500, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THIS RESULT WAS DEEMED TO BE ERRONEOUS BY THE CUSTOMER. THE SAMPLE WAS REPEATED ON E601 SERIAL NUMBER (B)(4) AND RESULTED 7997. THE REPEAT RESULT WAS DEEMED TO BE THE CORRECT RESULT BY THE CUSTOMER. THERE WAS NO ADVERSE EVENT. ON (B)(6) 2013, PATIENT 3 WAS RESULTED ON E601 SERIAL NUMBER (B)(4) AS 0.500, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THIS RESULT WAS DEEMED TO BE ERRONEOUS BY THE CUSTOMER. THE SAMPLE WAS REPEATED ON E601 SERIAL NUMBER (B)(4) AS 3325. THE REPEAT RESULT WAS DEEMED TO BE THE CORRECT RESULT BY THE CUSTOMER. THERE WAS NO ADVERSE EVENT. ON (B)(6) 2013, PATIENT 4 WAS RESULTED ON E601 SERIAL NUMBER (B)(4) AS 798.0. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS DEEMED TO BE THE CORRECT RESULT BY THE CUSTOMER. THE SAMPLE WAS THEN REPEATED ON E601 SERIAL NUMBER (B)(4). THE REPEAT RESULT WAS 0.523. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. THE LOT OF HCG STAT REAGENT IN USE WAS 17011701, WITH AN EXPIRATION DATE OF (B)(6) 2014. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE LIQUID LEVEL DETECTION BOARD. HE REPLACED THE LIQUID LEVEL DETECTION BOARD. THE CUSTOMER PERFORMED CALIBRATIONS AND QC. THE CUSTOMER WAS SATISFIED WITH THE QC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90630 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1