BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3230077 · Received July 16, 2013

    Report

    Report Number
    1823260-2013-04293
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED FOR CALCIUM. THE FIRST SAMPLE INITIALLY RESULTED AS 11.0 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND RESULTED AS 8.8 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE SECOND SAMPLE INITIALLY RESULTED AS 12.4 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND RESULTED AS 10.1 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE DOCTOR ORDERED AN ADDITIONAL PTH TEST ON PATIENT TWO BASED ON THE ERRONEOUS RESULT, BUT THE PATIENT WAS NOT ADVERSELY AFFECTED BY HAVING THIS TEST ORDERED. THE CALCIUM REAGENT LOT NUMBER WAS 67512501 WITH AN EXPIRATION DATE OF (B)(6) 2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED ALL ALIGNMENTS AND VERIFIED THAT THE PROBE VOLUME WAS WITHIN SPECIFICATIONS WITH THE STREAM BEING STRAIGHT AND NOT JAGGED. THE GEAR PUMP READ CORRECTLY. ALL QUALITY CONTROLS WERE RUN AND WITHIN RANGE. A PRECISION STUDY WAS PERFORMED ON A POOLED SAMPLE AND THIS LOOKED GOOD. THE FIELD SERVICE REPRESENTATIVE NOTED THAT THERE MAY HAVE BEEN A SAMPLE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328398 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1