BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3549979 · Received January 3, 2014

    Report

    Report Number
    1823260-2014-00055
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 7, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    REVIEW OF THE PROVIDED CALIBRATION DATA INDICATED PROBLEMS WITH CUSTOMER HANDLING OF THE INTERNAL STANDARD SOLUTION SUCH AS EVAPORATION OR POOLING OF THE SOLUTION. THIS ISSUE WAS THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) RESULTS FOR 19 PATIENT SAMPLES. THE ER DOCTOR QUESTIONED THE HIGH RESULTS AND THE CUSTOMER INVESTIGATED. OF THE DATA PROVIDED, THE FOLLOWING RESULTS WERE DISCREPANT. PATIENT SAMPLE #1: INITIAL: SODIUM 156 MMOL/L WITH A DATA FLAG, CHLORIDE 115 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 139 MMOL/L, CHLORIDE 104 MMOL/L. PATIENT SAMPLE #2: INITIAL: SODIUM 146 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 136 MMOL/L. PATIENT SAMPLE #3: INITIAL: SODIUM 153 MMOL/L WITH A DATA FLAG, CHLORIDE 108 MMOL/L. REPEAT: SODIUM 137 MMOL/L, CHLORIDE 98 MMOL/L. PATIENT SAMPLE #4: INITIAL: SODIUM 148 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 140 MMOL/L. PATIENT SAMPLE #5: INITIAL: SODIUM 160 MMOL/L WITH A DATA FLAG, POTASSIUM 4.8 MMOL/L, CHLORIDE 110 MMOL/L. REPEAT: SODIUM 134 MMOL/L, POTASSIUM 4.2 MMOL/L, CHLORIDE 97 MMOL/L. PATIENT SAMPLE #6: INITIAL: SODIUM 151 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 139 MMOL/L. PATIENT SAMPLE #7: INITIAL: SODIUM 149 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 140 MMOL/L. PATIENT SAMPLE #8: INITIAL: SODIUM 145 MMOL/L. REPEAT: SODIUM 133 MMOL/L. PATIENT SAMPLE #9: INITIAL: SODIUM 151 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 139 MMOL/L. PATIENT SAMPLE #10: INITIAL: SODIUM 162 MMOL/L WITH A DATA FLAG, CHLORIDE 118 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 162 WITH A DATA FLAG AND 141 MMOL/L, CHLORIDE 105 MMOL/L. PATIENT SAMPLE #11: INITIAL: SODIUM 141 MMOL/L. REPEAT: SODIUM 134 MMOL/L. PATIENT SAMPLE #12: INITIAL: SODIUM 152 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 139 MMOL/L. PATIENT SAMPLE #13: INITIAL: SODIUM 151 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 138 MMOL/L. PATIENT SAMPLE #14: INITIAL: SODIUM 143 MMOL/L. REPEAT: SODIUM 132 MMOL/L. PATIENT SAMPLE #15: INITIAL: SODIUM 152 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 139 MMOL/L. PATIENT SAMPLE #16: INITIAL: SODIUM 155 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 143 MMOL/L. PATIENT SAMPLE #17: INITIAL: SODIUM 147 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 136 MMOL/L. PATIENT SAMPLE #18: INITIAL: SODIUM 154 MMOL/L WITH A DATA FLAG, CHLORIDE 113 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 140 MMOL/L, CHLORIDE 102 MMOL/L. PATIENT SAMPLE #19: INITIAL: SODIUM 151 MMOL/L WITH A DATA FLAG. REPEAT: SODIUM 145 MMOL/L. ALL OF THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. NO PATIENTS WERE ADVERSELY AFFECTED. THE SODIUM, POTASSIUM AND CHLORIDE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS AIR IN THE REFERENCE LINE. AFTER REPLACING THE KCL FILTER, THE OPERATOR HAD TO TROUBLESHOOT FOR SEVERAL HOURS TO GET ISE CALIBRATION IN SPECIFICATION. HE FOUND IT WAS LIKELY THAT AIR REMAINED IN THE REFERENCE PATHWAY HE ADJUSTED THE ISE REAGENT PROBE, EXAMINED REFERENCE SOLUTION PIPETTING, TUBING, AND REFERENCE ELECTRODE. HE CHECKED THE ACRYLIC BLOCK FITTINGS. HE NOTED SINCE (B)(6) 2013, ALL CALIBRATIONS AND QC HAVE BEEN IN SPECIFICATION. HE RAN 20 ISE CHECKS WHICH PASSED AND THE OPERATOR RAN ISE PRECISION CHECK WITH POOLED SAMPLES. HE RAN ISE CALIBRATION AND QC WITH ALL TESTS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3306 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1