TINA-QUANT FERRITIN GEN.4

Additional Manufacturer Narrative

MEDWATCH FIELD D4 CATALOG NUMBER HAS BEEN UPDATED.

Additional Manufacturer Narrative

THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLE FERR4 TINA-QUANT FERRITIN GEN.4 RESULT FOR ONE PATIENT SAMPLE WITH THE COBAS 6000 C 501 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 495 NG/ML. THE REPEATED RESULT RUN IN REDUCED VOLUME WAS 147 NG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER IS QUESTIONING AN INTERFERENCE DUE TO PREVIOUS RESULTS SHOWING THE SAME PATTERN OF AN INITIALLY HIGH RESULT REPEATING LOWER.

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR INVESTIGATION AND TESTED USING A C501 AND AN E601. THE CUSTOMER¿S RESULTS COULD BE REPRODUCED. A DIFFERENCE BETWEEN THE FERRITIN CONCENTRATION VALUE GENERATED ON C501 IN NORMAL MODE AND THE FERRITIN VALUE GENERATED ON E601 COULD BE ALSO SEEN CLEARLY. THE RESULTS INDICATE AN INTERFERENT IN THE SAMPLE THAT INTERFERES WITH THE CLINICAL CHEMISTRY ASSAY FORMAT BUT HAS NO INFLUENCE ON THE ELECSYS ASSAY RESULT. THE PATIENT¿S MEDICATIONS WERE FURTHER INVESTIGATED FOR POTENTIAL INTERFERENCE. NONE OF THE TESTED ACTIVE COMPOUNDS OF THE MEDICATIONS SHOWED INTERFERENCE IN THE ASSAY. A FURTHER, MORE DETAILED CHARACTERIZATION OF THE POTENTIAL INTERFERING COMPOUND IS NOT POSSIBLE WITH THE REMAINING SAMPLE MATERIAL. THE INVESTIGATION FOUND THE ISSUE TO BE CONSISTENT WITH A SAMPLE-SPECIFIC UNKNOWN INTERFERENT. A PRODUCT PROBLEM COULD NOT BE FOUND.