BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 2221314 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04527
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 13, 2011
    Report Date
    November 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ANOTHER ANALYZER ASSOCIATED WITH THIS EVENT IS REPORTED IN THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. ANOTHER ANALYZER ASSOCIATED WITH THIS EVENT IS REPORTED IN THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION FOUND THE ISSUE MAY HAVE BEEN CAUSED BY A COMBINATION OF NON-OPTIMAL PREANALYTIC CONDITIONS AND MAINTENANCE PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ONGOING ISSUE FOR "SOME TIME" WITH LOW SODIUM RESULTS (FOR EXAMPLE 130 MMOL/L). THE REPEAT MEASUREMENTS USUALLY PRODUCED SIMILARLY LOW VALUES, BUT SOMETIMES THE 2ND OR 3RD REPEAT MEASUREMENTS RECOVERED HIGHER (FOR EXAMPLE 142 MMOL/L). THE CUSTOMER PROVIDED SPECIFIC RESULTS FOR FIVE PATIENT SAMPLES. TESTING WAS PERFORMED ON TWO INTEGRA 800 ANALYZERS, (INTEGRA 1 IS SERIAL NUMBER (B)(4) AND INTEGRA 2 IS SERIAL NUMBER (B)(4)). PATIENT 1, INITIAL RESULT TESTED ON INTEGRA 1, WAS 124 MMOL/L. THE SAMPLE WAS REPEATED 10 TIMES: REPEAT 1, TESTED ON INTEGRA 1, WAS 128 MMOL/L. REPEAT 2, TESTED ON INTEGRA 2, WAS 136 MMOL/L. REPEAT 3, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 136.7 MMOL/L. REPEAT 4, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 136.2 MMOL/L. REPEAT 5, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 136.6 MMOL/L. REPEAT 6, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 136.5 MMOL/L. REPEAT 7, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 135.0 MMOL/L. REPEAT 8, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 136.3 MMOL/L. REPEAT 9, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 136.5 MMOL/L. REPEAT 10, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 124.8 MMOL/L. PATIENT 2, INITIAL RESULT TESTED (B)(6) 2011 ON INTEGRA 1, WAS 131 MMOL/L. THE SAMPLE WAS REPEATED 9 TIMES: REPEAT 1, TESTED ON INTEGRA 2, WAS 141 MMOL/L. REPEAT 2, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 141.2 MMOL/L. REPEAT 3, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 142.2 MMOL/L. REPEAT 4, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 140.9 MMOL/L. REPEAT 5, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 140.0 MMOL/L. REPEAT 6, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 132.2 MMOL/L. REPEAT 7, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 138.0 MMOL/L. REPEAT 8, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 137.5 MMOL/L. REPEAT 9, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 137.6 MMOL/L. PATIENT 3, INITIAL RESULT TESTED (B)(6) 2011 ON INTEGRA 1, WAS 128 MMOL/L. THE SAMPLE WAS REPEATED 9 TIMES: REPEAT 1, TESTED ON INTEGRA 1, WAS 138 MMOL/L. REPEAT 2, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 139.5 MMOL/L. REPEAT 3, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 131.6 MMOL/L. REPEAT 4, TESTED 04/14/2011 ON INTEGRA 2, WAS 138.6 MMOL/L. REPEAT 5, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 139.8 MMOL/L. REPEAT 6, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 131.0 MMOL/L. REPEAT 7, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 132.8 MMOL/L. REPEAT 8, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 128.7 MMOL/L. REPEAT 9, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 130.6 MMOL/L. PATIENT 4, INITIAL RESULT TESTED (B)(6) 2011 ON INTEGRA 1, WAS 130 MMOL/L. THE SAMPLE WAS REPEATED 10 TIMES: REPEAT 1, TESTED ON INTEGRA 1, WAS 133 MMOL/L. REPEAT 2, TESTED ON INTEGRA 2, WAS 139 MMOL/L. REPEAT 3, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 139.8 MMOL/L. REPEAT 4, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 139.8 MMOL/L. REPEAT 5, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 140.5 MMOL/L. REPEAT 6, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 139.0 MMOL/L. REPEAT 7, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 137.2 MMOL/L. REPEAT 8, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 136.9 MMOL/L. REPEAT 9, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 131.6 MMOL/L. REPEAT 10, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 130.8 MMOL/L. PATIENT 5, INITIAL RESULT TESTED (B)(6) 2011 ON INTEGRA 1, WAS 118 MMOL/L. THE SAMPLE WAS REPEATED 9 TIMES: REPEAT 1, TESTED ON INTEGRA 1, WAS 132 MMOL/L. REPEAT 2, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 133.7 MMOL/L. REPEAT 3, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 134.7 MMOL/L. REPEAT 4, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 133.9 MMOL/L. REPEAT 5, TESTED (B)(6) 2011 ON INTEGRA 2, WAS 132.9 MMOL/L. REPEAT 6, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 131.4 MMOL/L. REPEAT 7, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 131.4 MMOL/L. REPEAT 8, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 131.8 MMOL/L. REPEAT 9, TESTED (B)(6) 2011 ON INTEGRA 1, WAS 131.4 MMOL/L. THE INITIAL SODIUM RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE REPEATED BECAUSE THE CUSTOMER SUSPECTED THE RESULTS WERE LOW. NO PATIENT WAS TREATED BASED ON THE LOW RESULTS. ONE OF THE ANALYZERS (UNSPECIFIED) HAD THE WHOLE ION SELECTIVE ELECTRODE (ISE) UNIT REPLACED, AS WELL AS BOTH SAMPLE PROBES AND ALL ISE ELECTRODES WHICH DID NOT AFFECT THE RESULTS. PERFORMANCE TESTS INCLUDING CALIBRATION AND QUALITY CONTROL WERE PERFORMED AND WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1