BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2922397 · Received January 18, 2013

    Report

    Report Number
    1823260-2013-00336
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 RECEIVED INTERMITTENT LOW RESULTS FOR MULTIPLE ASSAYS FOR A WEEK AND STATED FIVE PATIENT SAMPLES WERE INVOLVED. THE SAMPLES WERE REPEATED ON COBAS C501 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR THREE PATIENTS WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. PATIENT 1 HAD A SAMPLE TESTED AT 00:38. THE INITIAL ION SELECTIVE ELECTRODE (ISE) SODIUM RESULT WAS 118 MMOL/L AND THE INITIAL CHLORIDE RESULT WAS 86 MMOL/L. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT SODIUM RESULT WAS 139 MMOL/L AND THE REPEAT CHLORIDE RESULT WAS 104 MMOL/L. PATIENT 1 HAD A SECOND SAMPLE TESTED AT 04:08. THE INITIAL SODIUM RESULT WAS 109 MMOL/L, THE INITIAL POTASSIUM RESULT WAS 3.5 MMOL/L AND THE INITIAL CHLORIDE RESULT WAS 81 MMOL/L. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT SODIUM RESULT WAS 136 MMOL/L, THE REPEAT POTASSIUM RESULT WAS 4.5 AND THE REPEAT CHLORIDE RESULT WAS 105 MMOL/L. PATIENT 2 WAS A (B)(6) FEMALE. THE INITIAL CALCIUM RESULTS WERE 2.5 AND 2.7 MG/DL. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY AS <6.5 MG/DL. THE REPEAT CALCIUM RESULT WAS 9.5 MG/DL. PATIENT 3 INITIAL SODIUM RESULT WAS 109 MMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 140 MMOL/L. THE PATIENTS WERE NOT HARMED DUE TO THE LOW RESULTS RELEASED. THE SODIUM, POTASSIUM AND CHLORIDE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE CALCIUM REAGENT LOT NUMBER WAS 67085901 WITH AN EXPIRATION DATE OF 04/30/2013. THE FIELD SERVICE REPRESENTATIVE FOUND DEBRIS IN RINSE MECHANISM VACUUM NOZZLE AND REMOVED IT. HE REPLACED THE RINSE MECHANISM TUBING AS PART OF NORMAL MAINTENANCE. TO VERIFY THE ANALYZER OPERATION, THE CUSTOMER RAN QC WITH RESULT WITHIN THE LABORATORY SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27451 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR