COBAS 6000 C501 MODULE

Description of Event or Problem

IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY PROCEDURE, THE DEVICE WOULD NOT STAPLE. THE STAPLES WOULD COME OUT, HOWEVER, NOT STAPLE INTO THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

Description of Event or Problem

THE CUSTOMER RECEIVED DISCREPANT IGA RESULTS FOR ONE PATIENT SAMPLE. PRIOR TO RUNNING THE INITIAL RESULT OF 303 MG/DL, LEVEL 2 (IMMUNO 3) QUALITY CONTROL WAS OUT OF RANGE. THIS INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. QUALITY CONTROL WAS WITHIN THE EXPECTED RANGE PRIOR TO ALL THE REPEAT TESTING AND ALL REPEAT TESTING WAS PERFORMED ON THE SAME COBAS 6000 C501 ANALYZER. THE FIRST REPEAT IGA RESULT, RUN (B)(6) 2010, WAS 274 MG/DL. THE SECOND REPEAT IGA RESULT, RUN (B)(6) 2010, WAS 264 MG/DL. THE THIRD REPEAT IGA RESULT, RUN (B)(6) 2010, WAS 239 MG/DL. THE FOURTH REPEAT IGA RESULT, RUN (B)(6) 2010, WAS GENERATED WITH A DILUTION (1:10) AND GAVE 3300 MG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AS A CORRECTED REPORT. THE FIFTH REPEAT IGA RESULT, RUN (B)(6) 2010, WAS GENERATED WITH A DILUTION (1:20) AND GAVE 3340 MG/DL. THE PATIENT WAS NOT AFFECTED BY THE ERRONEOUS RESULTS. THE IGA REAGENT LOT NUMBER WAS 63308901. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE A CAUSE OR REPRODUCE THE DISCREPANCIES. HE PERFORMED PRECISION TESTS BOTH WITH UNDILUTED AND DILUTED SAMPLE POOLS. HE RAN PERFORMANCE TESTS AND THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROL. ALL RESULTS WERE ACCEPTABLE.

Additional Manufacturer Narrative

DATA PROVIDED BY THE CUSTOMER WAS INVESTIGATED. THE INITIAL RESULT AND SUBSEQUENT THREE REPEAT RESULTS WERE LOW. THE TRUE RESULT WAS >3000 MG/DL. THE PATIENT WAS VERY LIKELY A MYELOMA PATIENT WITH HIGH IGA AND LAMBDA LIGHT CHAIN VALUES. THE CUSTOMER USED THE PEDIATRIC (SENSITIVE) APPLICATION FOR IGA. THIS IS NOT RECOMMENDED FOR ROUTINE AND SCREENING PURPOSES. THIS APPLICATION WAS DESIGNED FOR SENSITIVE LOW END DETERMINATION ESPECIALLY FOR NEONATES AND PEDIATRIC PATIENTS. ACCORDING TO PRODUCT LABELING, IGA CONCENTRATIONS >20 G/L MAY LEAD TO ERRONEOUSLY LOW RESULTS. THE STANDARD IGA APPLICATION SHOULD HAVE BEEN USED TO DETERMINE THE PATIENT'S CORRECT IGA RESULTS. THIS APPLICATION CONTAINS PROZONE LIMITS TO DETECT FALSELY LOW RESULTS DUE TO ANTIGEN EXCESS UP TO 100 G/L. THE CUSTOMER WAS INFORMED AND HAS MOVED TO THE STANDARD APPLICATION THE CUSTOMER COULD NOT PROVIDE DETAILED PATIENT INFORMATION BUT CONFIRMED THAT THE PATIENT WAS NOT AFFECTED.