BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2023898 · Received March 18, 2011

    Report

    Report Number
    1823260-2011-01495
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 7, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE ROOT CAUSE WAS MOST LIKELY A PRE- ANALYTICAL ISSUE. UNFORTUNATELY, THE CUSTOMER DID NOT PROVIDE ANY SUPPORTING DATA SUCH AS REACTION KINETICS, THEREFORE A DETAILED INVESTIGATION COULD NOT BE PERFORMED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER EXPERIENCED ERRATIC ION SELECTIVE ELECTRODE (ISE) RESULTS FOR TWO PATIENT SAMPLES THAT WERE DISCOVERED WHEN A DOCTOR CALLED TO QUESTION THE RESULTS. UPON INVESTIGATION, THE ISE SODIUM, ISE POTASSIUM, CALCIUM, CREATININE JAFFE GENERATION 2 (CREATININE) AND TOTAL PROTEIN GENERATION 2 (TOTAL PROTEIN) RESULTS WERE DISCREPANT. THE USER STATED THE SAMPLES WERE RETESTED ON (B)(6) 2011 AND THE RESULTS WERE CLOSE TO THE ORIGINAL RESULTS. NO SPECIFIC DATA WAS PROVIDED. AFTER THE REPEAT TESTING ON (B)(6) 2011, THE USER RECALIBRATED AND THEN REPEATED THE SAMPLES ON (B)(6) 2011. PATIENT SAMPLE 1 INITIAL SODIUM RESULT WAS 120 MMOL/L AND THE REPEAT RESULT ON (B)(6) 2011 WAS 145 MMOL/L. ON (B)(6) 2011 THE RESULTS WERE 138 MMOL/L AND 137 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 4.1 MMOL/L AND THE REPEAT RESULT ON (B)(6) 2011 WAS 5.0 MMOL/L. ON (B)(6) 2011 THE REPEAT RESULT WAS 4.7 MMOL/L TWICE. THE INITIAL CALCIUM RESULT WAS 7.2 MG/DL AND THE REPEAT RESULT ON (B)(6) 2011 WAS 9.1 MG/DL AND 9.0 MG/DL. THE INITIAL CREATININE RESULT WAS 0.8 MG/DL AND THE REPEAT RESULTS ON (B)(6) 2011 WAS 1.05 MG/DL WHICH WAS ROUNDED TO 1.1 MG/DL AND 1.03 MG/DL. THE INITIAL TOTAL PROTEIN RESULT WAS 4.7 G/DL AND THE REPEAT RESULT ON (B)(6) 2011 WAS 6.5 G/DL TWICE. PATIENT SAMPLE 2 INITIAL SODIUM RESULT WAS 116 MMOL/L AND THE REPEAT RESULT ON (B)(6) 2011 WAS 142 MMOL/L. ON (B)(6) 2011 THE REPEAT RESULTS WERE 138 MMOL/L AND 140 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 4.2 MMOL/L AND THE REPEAT RESULT ON (B)(6) 2011 WAS 4.8 MMOL/L. ON (B)(6) 2011 THE REPEAT RESULTS WERE 4.8 MMOL/L AND 4.9 MMOL/L. THE INITIAL CALCIUM RESULT WAS 7.3 MG/DL AND THE REPEAT RESULTS ON (B)(6) 2011 WERE 9.6 MG/DL AND 9.7 MG/DL. THE INITIAL CREATININE RESULT WAS 0.9 MG/DL AND THE REPEAT RESULTS ON (B)(6) 2011 WERE 1.18 MG/DL WHICH WAS ROUNDED TO 1.2 MG/DL AND 1.18 MG/DL. THE INITIAL TOTAL PROTEIN RESULT WAS 5.1 G/DL AND THE REPEAT RESULTS ON (B)(6) 2011 WERE 6.8 G/DL AND 6.9 G/DL. THE USER STATED SOME OF THE RESULTS WERE FLAGGED BY THE ANALYZER, BUT COULD NOT PROVIDE INFORMATION WHICH RESULTS WERE FLAGGED. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE DOCTOR AT THE FACILITY DECLINED TO PROVIDED FURTHER INFORMATION CONCERNING THE PATIENTS. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE SODIUM ELECTRODE LOT NUMBER WAS 21501724. THE POTASSIUM ELECTRODE LOT NUMBER WAS 21502434. THE CALCIUM REAGENT LOT NUMBER WAS 62802801. THE CREATININE REAGENT LOT NUMBER WAS 63093101. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 63225501. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND COULD NOT REPRODUCE THE ISSUE. HE VERIFIED THE PIPETTING AND PERFORMED A PRECISION CHECK. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL WITH RESULTS WITHIN THEIR ACCEPTABLE RANGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1