BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE UNIT

    MDR report key: 6417530 · Received March 20, 2017

    Report

    Report Number
    1823260-2017-00584
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    November 30, 2016
    Report Date
    March 21, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. CLARIFICATION OF THE INFORMATION WAS REQUESTED, BUT THE CUSTOMER REFUSED TO PROVIDE FURTHER INFORMATION. THE CREATININE AND UREA REACTION KINETICS WERE REVIEWED AND SHOWED A REGULAR CURVED COURSE IN ALL SAMPLES. INTERFERENCE, POSSIBLY FROM THE RISPERIDON COULD BE EXCLUDED AS THE CREATININE RESULTS CORRELATED WITH THE UREA RESULTS. AN INFLUENCE FROM BILIRUBIN AND GLUCOSE COULD ALSO BE EXCLUDED AS THE VALUES ARE NOT HIGH ENOUGH. DURING EVALUATION OF THE ISSUE WITH POTASSIUM, THE RESULTS PROVIDED WERE DETERMINED TO BE IMPLAUSIBLE. IT WAS REPORTED THAT THE FIRST ELEVATED RESULT WAS FROM A LI-HEPARIN PLASMA TUBE AND THE SECOND, REPEAT RESULT WAS FROM A K3 EDTA PLASMA TUBE. HOWEVER, THE USE OF K3 EDTA PLASMA WOULD LEAD TO ELEVATED POTASSIUM RESULTS AND IS NOT SUITABLE FOR POTASSIUM TESTING. THEREFORE, THE ROOT CAUSE FOR THE ELEVATED POTASSIUM RESULT IS UNKNOWN. IT WAS LIKELY THE HIGH RESULT WAS ACTUALLY GENERATED FROM THE K3 EDTA SAMPLE.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6). PHONE WAS PROVIDED AS "(B)(6)".

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT. THE INITIAL RESULTS FROM SAMPLE 1 (LI-HEPARIN) WERE: CREJ2 CREATININE JAFFÉ GEN.2: 635.4 UMOL/L, PHOS2 PHOSPHATE (INORGANIC) VER.2: 3.49 MMOL/L, ISE INDIRECT NA, K, CI FOR GEN.2 POTASSIUM: 8.65 MMOL/L, THESE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENT WAS REDRAWN AND THE RESULTS FROM SAMPLE 2 (K3-EDTA) WERE: CREATININE: 212.7 UMOL/L, UREAL UREA/BUN: 9.4MMOL/L, PHOSPHORUS: 1.93 MMOL/L, POTASSIUM: 5.68 MMOL/L. THE FOLLOWING ADDITIONAL RESULTS FROM (B)(6) 2016 WERE PROVIDED, BUT IT WAS UNCLEAR WHICH SAMPLE WAS USED FOR THE TESTING. CLARIFICATION WAS REQUESTED BUT COULD NOT BE PROVIDED. POTASSIUM: 5.71 MMOL/L, CREATININE: 209.8 UMOL/L. ON (B)(6) 2016, THE CUSTOMER REPEATED BOTH SAMPLES: SAMPLE 1: CREATININE: 212 UMOL/L, UREA: 9.9 MMOL/L. SAMPLE 2: CREATININE: 40 UMOL/L, UREA: 4.5 MMOL/L. ALL REPEAT TESTING WAS PERFORMED ON THE SAME ANALYZER AND WAS CONFIRMED ON ANOTHER COBAS 6000 C (501) AT THE SITE. NO SPECIFIC DATA FROM THE OTHER ANALYZER WAS PROVIDED. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CREATININE REAGENT LOT NUMBER WAS 193429. THE PHOSPHORUS REAGENT LOT NUMBER WAS 175805. THE UREA REAGENT LOT NUMBER WAS 187429. THE POTASSIUM ELECTRODE LOT NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENT CAME FROM THE NEUROPEDIATRIC AMBULANCE WITH NO KNOWN RENAL DISEASES. AS NO INFUSION WAS GIVEN AND THE BLOOD WAS DRAWN CORRECTLY FROM THE VEIN, THE LABORATORY PHYSICIAN EXCLUDED A SAMPLE MIX UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200990 COBAS 6000 CORE UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 6000 CORE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR RISPERIDON