BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1668647 · Received April 28, 2010

    Report

    Report Number
    1823260-2010-02522
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    April 9, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED VALVE V71 WAS NOT RECEIVING A PROPER VOLTAGE SIGNAL FROM THE ISE CONTROLLER PCB AND THE ISE MAINTENANCE SETTINGS IN SYSTEM SOFTWARE WERE MISCONFIGURED FOR THE CUSTOMER'S SAMPLE TYPE AND VOLUME. HE REPLACED THE ISE CONTROLLER PCB, RECONFIGURED THE MAINTENANCE SETTINGS AND PERFORMED ELECTRODE SERVICE. TO VERIFY THE ANALYZER OPERATION, HE SUCCESSFULLY SET THE MIX/DRY ADJUSTMENT AND PERFORMED CALIBRATION IN DIAGNOSTICS. THE CUSTOMER SUCCESSFULLY CALIBRATED AND RAN CONTROLS TO THEIR SPECIFICATION.

    Description of Event or Problem · 1

    THE USER STATED ALL PATIENTS SEEMED TO BE RECOVERING LOW FOR SODIUM FOR OVER ONE WEEK. OF THE DATA PROVIDED, THE RESULTS FOR SEVEN PATIENT SAMPLES WERE DISCREPANT. THE RESULTS ARE LISTED AS INITIAL RESULT, RESULT ON (B) (6) 2010 AFTER THE USER REPLACED THE ISE SOLUTIONS AND RECALIBRATED AND THE REPEAT RESULT ON (B) (6) 2010 AFTER THE SERVICE VISIT. ALL RESULTS ARE IN MEQ/L. SAMPLE 1: 132, 134,139. SAMPLE 2: (FEMALE, (B) (6)) 134, 136, 140. SAMPLE 3: (FEMALE, (B) (6)) 133, 137, 139. SAMPLE 4: (MALE, (B) (6)) 128, 131, 135. SAMPLE 5: (MALE, (B) (6)) 132, 135, 138. SAMPLE 6: (FEMALE, (B) (6)) 134, 138, 141. SAMPLE 7: (MALE, (B) (6)) 131, 130, 137. THE ONLY ERRONEOUS RESULT REPORTED WAS THE RESULT OF 130 MEQ/L FOR SAMPLE 7. THE USER STATED THEY HAD INFORMED THE PHYSICIAN THAT THE SODIUM RESULT WAS SUSPECT, AND THEY WERE PLANNING TO ADDRESS THE PROBLEM AND RERUN IT. THE PATIENT WAS NOT TREATED OR ADVERSELY AFFECTED ON THE BASIS OF THE SODIUM RESULT. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A BAD SAMPLE PROBE AND THE ISE AIR-MIX WAS OUT OF ADJUSTMENT. HE HAD THE USER REPLACE THE SAMPLE PROBE C AND ADJUSTED THE ISE AIR-MIX. TO VERIFY THE ANALYZER OPERATION, THE CALIBRATION WAS RUN THREE TIMES SUCCESSFULLY AND THE USER RAN CALIBRATION AND QC WITH NO ISSUES.

    Description of Event or Problem · 1

    THE USER STATED BEGINNING (B) (6) 2010, THEY HAD BEEN GETTING PHYSICIAN COMPLAINTS ABOUT HIGH PARATHYROID HORMONE VALUES BEING REPORTED. THE USER COULD NOT PROVIDED SPECIFIC PATIENT DATA, BUT PERFORMED A 15 SAMPLE COMPARISON WITH ANOTHER LAB THAT WAS USING AN IMMULITE ANALYZER. OF THE DATA PROVIDED, THE RESULTS FOR 14 SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN PG/ML. SAMPLE 1 INITIAL RESULT WAS 368, IMMULITE RESULT WAS 678. SAMPLE 2 INITIAL RESULT WAS 236, IMMULITE RESULT WAS 396. SAMPLE 3 INITIAL RESULT WAS 105, IMMULITE RESULT WAS 173. SAMPLE 4 INITIAL RESULT WAS 54, IMMULITE RESULT WAS 113. SAMPLE 5 INITIAL RESULT WAS 636, IMMULITE RESULT WAS 1383. SAMPLE 6 INITIAL RESULT WAS 13, IMMULITE RESULT WAS 8.74. SAMPLE 7 INITIAL RESULT WAS 123, IMMULITE RESULT WAS 39.7. SAMPLE 8 INITIAL RESULT WAS 356, IMMULITE RESULT WAS 33. SAMPLE 9 INITIAL RESULT WAS 143, IMMULITE RESULT WAS 262. SAMPLE 10 INITIAL RESULT WAS 465, IMMULITE RESULT WAS 986. SAMPLE 11 INITIAL RESULT WAS 393, IMMULITE RESULT WAS 766. SAMPLE 12 INITIAL RESULT WAS 84, IMMULITE RESULT WAS 155. SAMPLE 13 INITIAL RESULT WAS 90, IMMULITE RESULT WAS 116. SAMPLE 14 INITIAL RESULT WAS 112, IMMULITE RESULT WAS 193. NO PATIENTS WERE AFFECTED. THE SAMPLES WERE RUN FOR A METHOD COMPARISON AND NO PATIENT DIAGNOSIS OR TREATMENT WAS MADE BASED ON THESE RESULTS. THE PTH REAGENT LOT NUMBER WAS 15670104. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE PERFORMED MECHANICAL CHECKS AND CORRECTIVE MAINTENANCE. HE VERIFIED THE ANALYZER OPERATION BY RUNNING PERFORMANCE TESTS WITH PASSING RESULTS.

    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
    1 053 YR