BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1658334 · Received April 14, 2010

    Report

    Report Number
    1823260-2010-02216
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 4, 2010
    Report Date
    April 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    USER EXPERIENCED ISSUE WITH LOW CONTROL RECOVERY AND PATIENT RESULTS FOR SODIUM. USER PROVIDED RESULTS FOR 24 PATIENT SAMPLES, 9 WERE DISCREPANT FOR SODIUM AND OR POTASSIUM. PATIENT SAMPLES WERE INITIALLY TESTED BETWEEN (B) (6) 2010 AND (B) (6) 2010, EXACT DATE OF TESTING WAS NOT PROVIDED EXCEPT FOR SAMPLE 1, WHICH WAS INITIALLY TESTED ON (B) (6) 2010. ALL SAMPLES WERE REPEATED ON 03/19/2010 AND RUN ON ANOTHER I400 PLUS (B) (4) AT THE SITE. SAMPLE 1, INITIAL SODIUM GAVE 129; REPEAT GAVE 136 MMOL/L. SAMPLE 2, INITIAL SODIUM GAVE 133; REPEAT GAVE 141 MMOL/L. SAMPLE 3, INITIAL SODIUM GAVE 134; REPEAT GAVE 143 MMOL/L. SAMPLE 4, INITIAL SODIUM GAVE 133; REPEAT GAVE 140 MMOL/L. SAMPLE 5, INITIAL SODIUM GAVE 132; REPEAT GAVE 140 MMOL/L. SAMPLE 6, INITIAL SODIUM GAVE 133; REPEAT GAVE 142 MMOL/L. SAMPLE 7, INITIAL SODIUM GAVE 134; REPEAT GAVE 140 MMOL/L. SAMPLE 8, INITIAL POTASSIUM GAVE 3.6; REPEAT GAVE 4.5 MMOL/L. SAMPLE 9, INITIAL POTASSIUM GAVE 3.9; REPEAT GAVE 4.3 MMOL/L. INITIAL RESULTS WERE REPORTED AND CORRECTED REPORTS WERE ISSUED ON (B) (6) 2010 USING THE REPEAT RESULTS. SAMPLE 1, ORDER WAS WRITTEN TO TAKE PATIENT OFF WATER RESTRICTION BASED ON THE INITIAL RESULTS REPORTED, BUT THE ORDER WAS NOT IMPLEMENTED BEFORE THE PATIENT SAMPLE WAS REPEATED AND THE CORRECTED REPORT WAS ISSUED. THE PATIENT WAS THEN TAKEN OFF THE RESTRICTION. NO ADVERSE EVENTS WERE REPORTED. SODIUM ELECTRODE LOT NUMBER - 21591514 POTASSIUM ELECTRODE LOT NUMBER # 21583817 USER FOUND THE ISE DIRECT CALIBRATOR BOTTLE HAD BEEN REPLACED WITH THE INDIRECT CALIBRATOR BOTTLE, AND REPLACED THE BOTTLE WITH THE CORRECT DIRECT CALIBRATOR BOTTLE. USER PRIMED CALIBRATORS AND PERFORMED CALIBRATION WHICH PASSED. CONTROLS WERE RUN AND RECOVERED LOW OUTSIDE RANGE. THE TECHNICAL SUPPORT SPECIALIST RECOMMENDED THE USER PERFORM CORRECTIVE MAINTENANCE, RUN CALIBRATION AND CONTROLS TO CHECK RECOVERY. USER PERFORMED THE RECOMMENDED ACTIONS AND CONTROLS RECOVERED WITHIN RANGE WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR