BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3071147 · Received April 22, 2013

    Report

    Report Number
    1823260-2013-02456
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE BASED ON THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM AND POTASSIUM RESULTS FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED, ONLY THE SODIUM RESULTS WERE DISCREPANT. THE ORIGINAL SODIUM RESULT FROM THE PRIMARY TUBE WAS 122 MMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT, WHO WAS AN OUTPATIENT, WAS CALLED INTO THE ER BASED ON THE RESULT. ANOTHER SAMPLE WAS COLLECTED IN THE ER AND THE RESULTS DID NOT MATCH. SPECIFIC DATA WAS NOT PROVIDED. THE ORIGINAL SAMPLE WAS POURED OFF AND RE-CENTRIFUGED. THE SAMPLE WAS THEN REPEATED ON THE SAME MODULE AND ON ANOTHER C501 WITH RESULTS OF 133 AND 135 MMOL/L. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT BECAUSE THEY MATCHED THE OTHER SAMPLE THAT WAS COLLECTED WHEN THE PATIENT WAS IN THE ER. THE PATIENT WAS DISCHARGED AND NO TREATMENT WAS GIVEN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER WAS T47 WITH AN EXPIRATION DATE OF 11/28/2013. THE CUSTOMER DECLINED A SERVICE VISIT AND STATED THAT BECAUSE ANOTHER 25 SAMPLES MATCHED PREVIOUS RESULTS, HE DEEMED THIS TO BE A SAMPLE SPECIFIC ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171676 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR MULTI-VITAMIN| HYDRODIURIL| METHOTREXATE| METOPROLOL| LOSARTAN| PREDNISONE| FOSAMAX| AMOXICILLIN| LOW DOSE ASPIRIN| VITAMIN D| POTASSIUM-CHLORIDE TABLETS