BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2792444 · Received October 16, 2012

    Report

    Report Number
    1823260-2012-05145
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    January 1, 2010
    Report Date
    November 8, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGZ
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING PROVIDES INFORMATION WITH RESPECT TO SALICYLATE INTERFERENCE. SALICYLATE CONCENTRATIONS OF 1.2 MMOL/L WILL CAUSE AN INTERFERENCE OF +10% WITH ISE CHLORIDE. IN ADDITION, THE INVESTIGATION DETERMINED THAT THE CUSTOMER WAS USING PLASMA SAMPLES. PRODUCT LABELING INDICATES THAT THE LIFETIME OF THE CHLORIDE ELECTRODE WILL BE REDUCED WITH THE USE OF PLASMA SAMPLES.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR SIX DIFFERENT PATIENTS TESTED FOR ION SELECTIVE ELECTRODE (ISE) CHLORIDE. THE PATIENT SAMPLES WERE ORIGINALLY TESTED ON THE INTEGRA 400+ ANALYZER BETWEEN THE DATES OF (B)(6) 2010 AND (B)(6) 2012. THE SAMPLES WERE REPEATED ON A "COBAS" ANALYZER AND THE REPEAT VALUES WERE CONSIDERED TO BE CORRECT. THE CUSTOMER FIRST REPORTED THAT THE ION SELECTIVE ELECTRODE (ISE) CHLORIDE ELECTRODES WERE NOT LASTING TO THE CLAIMED PERIOD OF EFFECTIVENESS. THEY SAID THAT THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE (PATIENT TWO) TESTED FOR CHLORIDE IN (B)(6) 2012 ON THE INTEGRA 400+ ANALYZER. THE CUSTOMER COULD NOT PROVIDE A SPECIFIC DATE FOR THE TESTING. THE QUESTIONABLE RESULT WAS 181 MMOL/L AND REPORTED OUTSIDE OF THE LABORATORY. THE CHLORIDE VALUE WAS CONFIRMED WITH SUBSEQUENT RETESTING; THE CUSTOMER DID NOT PROVIDE INFORMATION ON THE REPEAT VALUE. THE CHLORIDE RESULT CONTRIBUTED TO THE MEDICAL DECISION TO HEMODIALYZE THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE HEMODIALYSIS. THE CUSTOMER EXPLAINED THAT THEY BELIEVE THE ELEVATED CHLORIDE VALUES TO BE CAUSED BY INTERFERENCE OF SALICYLATE ON THE CHLORIDE ELECTRODE COMBINED WITH AGE OF THE ELECTRODE. PATIENT TWO WAS REPORTED TO HAVE A SALICYLATE VALUE OF 35 MG/DL. THE CUSTOMER STATED THAT FURTHER INVESTIGATION YIELDED SEVERAL CASES OF PATIENTS WITH MEASURABLE SALICYLATE CONCENTRATIONS AND EXTREMELY ELEVATED CHLORIDE RESULTS USING THE INTEGRA 400+. THE CUSTOMER PROVIDED DATA FROM SIX DIFFERENT PATIENTS WITH ERRONEOUS ELEVATED CHLORIDE VALUES. THE EXACT TOTAL OF SAMPLES COULD NOT BE CLARIFIED WITH THE CUSTOMER. ALL INITIAL ERRONEOUS VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLES WERE REPEATED USING A "COBAS" ANALYZER AND THE RESULTS FROM THIS ANALYZER WERE CONSIDERED TO BE CORRECT. A SAMPLE FROM PATIENT ONE ORIGINALLY RESULTED AS 146 MMOL/L FOR CHLORIDE AND IT WAS REPEATED ON A "COBAS" ANALYZER, RESULTING AS 111 MMOL/L. THE ORIGINAL AND REPEAT VALUES WERE OBTAINED SOMETIME IN (B)(6), BUT THE CUSTOMER COULD NOT CONFIRM ANY EXACT DATES. IN ADDITION TO THE 181 MMOL/L INTEGRA 400+ CHLORIDE VALUE FOR PATIENT TWO, THE CUSTOMER PROVIDED ADDITIONAL CHLORIDE VALUES FROM THIS PATIENT. IT COULD NOT BE CONFIRMED WITH THE CUSTOMER WHETHER THESE VALUES WERE FROM THE SAME SAMPLE OR DIFFERENT SAMPLES. THE SAMPLES WERE ORIGINALLY TESTED AND REPEATED IN (B)(6) 2012, BUT THE CUSTOMER COULD NOT CONFIRM ANY SPECIFIC DATES. THE INITIAL CHLORIDE VALUES FROM PATIENT TWO WERE 198 MMOL/L AND 167 MMOL/L ON THE INTEGRA 400 + ANALYZER. THE REPEAT VALUES FROM THE "COBAS" ANALYZER WERE 99 MMOL/L AND 104 MMOL/L. A SAMPLE FROM PATIENT THREE ORIGINALLY RESULTED AS 142 MMOL/L FOR CHLORIDE ON (B)(6) 2012 AND IT WAS REPEATED ON A "COBAS" ANALYZER ON (B)(6) 2012, RESULTING AS 104 MMOL/L. FOR PATIENT FOUR, THE CUSTOMER PROVIDED 2 INITIAL CHLORIDE VALUES FROM (B)(6) 2012, BUT IT COULD NOT BE CONFIRMED WITH THE CUSTOMER IF THESE VALUES WERE FROM THE SAME SAMPLE OR DIFFERENT SAMPLES. THE INITIAL VALUES WERE 198 MMOL/L AND 167 MMOL/L. THE CUSTOMER PROVIDED ONE REPEAT VALUE OF 104 MMOL/L PERFORMED ON (B)(6) 2012 ON THE "COBAS" ANALYZER . A SAMPLE FROM PATIENT FIVE ORIGINALLY RESULTED AS 131 MMOL/L FOR CHLORIDE ON (B)(6) 2011 AND IT WAS REPEATED ON A "COBAS" ANALYZER ON (B)(6) 2011, RESULTING AS 102 MMOL/L. A SAMPLE FROM PATIENT SIX ORIGINALLY RESULTED AS 181 MMOL/L FOR CHLORIDE ON (B)(6) 2012 AND IT WAS REPEATED ON A "COBAS" ANALYZER ON (B)(6) 2012, RESULTING AS 106 MMOL/L. THE CUSTOMER DID NOT KNOW IF ALL OTHER PATIENTS (EXCLUDING PATIENT TWO) WERE ADVERSELY AFFECTED BY THE EVENT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TO PROVIDE THE LOT NUMBER OR EXPIRATION DATE FOR THE CHLORIDE ELECTRODE IN USE. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROLS; THESE PASSED TO CUSTOMER SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1