BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 3182615 · Received June 21, 2013

    Report

    Report Number
    1823260-2013-03763
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    ON FURTHER FOLLOW UP, IT WAS DETERMINED THAT THE INITIAL SAMPLE WAS DRAWN AT 1:53PM ON (B)(6) 2013. THE RESULTS WERE RELEASED AT 8:30PM AND NOT 2:30PM AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED FOR INVESTIGATION. CONTAMINATION FROM A USED SAMPLE CUP COULD HAVE CAUSED THE DISCREPANT RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ION SELECTIVE ELECTRODE (ISE) POTASSIUM (K), CREATININE JAFFE GEN.2 (CREAJ) AND UREA/BUN (BUN) ON ONE PATIENT SAMPLE. THE K RESULTS ARE IN MMOL/L, THE CREAJ AND BUN RESULTS ARE IN MG/DL. THE ORIGINAL SAMPLE WAS DRAWN AT 2:00 PM ON (B)(6) 2013, AND WAS RUN AROUND 2:30 PM. THE INITIAL K RESULT WAS 9.6, ACCOMPANIED BY A DATA FLAG. THE K AUTO- REPEATED AND GENERATED A RESULT OF 9.74, ACCOMPANIED BY A DATA FLAG. THE INITIAL CREAJ RESULT WAS 17 AND THE INITIAL BUN RESULT WAS 107. THESE INITIAL RESULTS WERE CALLED TO THE PHYSICIAN. THE PHYSICIAN INSTRUCTED THE PATIENT TO REPORT TO THE "ER". THE PATIENT WAS REDRAWN ON (B)(6) 2013 AND THE RESULTS DID NOT CORRELATE WITH THE INITIAL RESULTS. THE ORIGINAL SAMPLE WAS REPEATED ON THE SAME C8000 AND ALSO A C6000. THE ORIGINAL SAMPLE WAS REPEATED FOR K ONLY AT 12:05 ON THE C6000. THAT RESULT WAS 4.4. THE SAMPLE WAS REPEATED AGAIN ON THE C6000 AT 12:20, BUT THE CUSTOMER DID NOT PROVIDE ANY RESULTS FROM THIS RUN. AT 12:29, THE ORIGINAL SAMPLE WAS REPEATED ON THE C8000. THE REPEAT K RESULT WAS 4.46, THE REPEAT CREAJ RESULT WAS 0.8, AND THE REPEAT BUN RESULT WAS 16. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THE CUSTOMER HAS NO ACCESS TO ANY PATIENT INFORMATION FROM THE "ER". IT IS UNKNOWN IF THERE WAS AN ADVERSE EVENT. THE LOT NUMBER OF THE CREAJ REAGENT IN USE WAS 67446401, WITH AN EXPIRATION DATE OF 09/30/2014. THE LOT NUMBER OF THE BUN REAGENT IN USE WAS 67403701, WITH AN EXPIRATION DATE OF 10/31/2013. THE LOT NUMBER OF THE K ELECTRODE IN USE WAS NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT DETERMINE A CAUSE. THE CUSTOMER INDICATED THAT IT WAS POSSIBLE A PREVIOUSLY USED SAMPLE CUP MAY HAVE BEEN REUSED. THE FSR PERFORMED A PRECISION RUN ON ALL THREE ASSAYS. THE CUSTOMER PERFORMED CALIBRATION AND QC AS APPROPRIATE, AND RESULTS WERE WITHIN SPECIFICATION. THE FSR NOTED THE ANALYZER WAS OPERATING WITHOUT ISSUE AND THE CUSTOMER HAD NO FURTHER QUESTIONABLE RESULTS AFTER SPEAKING WITH THE CALL CENTER AND WHEN HE ARRIVED AT THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282883 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1