Description of Event or Problem · 1
IN APRIL 2004, FDA REQUESTED THAT A SEPARATE MEDWATCH FORM BE FILED FOR THE SECOND OF TWO COBAS AMPLICOR TC UNIT THAT WERE IDENTIFIED IN MEDWATCH FORM 2243471-2003-00003 THAT WAS SUBMITTED IN NOVEMBER 2003. THE ROCHE INSTRUMENT CENTER (RIC) WAS NOTIFIED IN 2003 BY THE ROCHE DIAGNOSTICS SERVICE ORGANIZATION OF TWO CASES OF INCORRECT LABELING OF THE THERMAL CYCLE AND DETECTION POSITIONS IN THE COBAS AMPLICOR ANALYZER THERMAL CYCLER UNIT (TC UNIT). THE INCORRECT LABELING HAS BEEN FOUND ONLY ON REPLACEMENT THERMAL CYCLER UNITS. IN ONE CASE "TC A" WAS IDENTIFIED AS "TC B" AND "TC B" AS "TC A", AND IN THE SECOND CASE "DP 1" WAS IDENTIFIED AS "DP 2" AND "DP 2" AS "DP 1". IN EACH CASE, THE INCORRECT LABELING WAS DETECTED ALMOST IMMEDIATELY AFTER INSTALLATION OF THE REPLACEMENT UNIT, AND NO TEST RESULTS WERE REPORTED. THE INCORRECT LABELING RESULTS IN A SAMPLE-TO-RESULT MISMATCH ISSUE. THE RESULTS OF A-RING 1 ARE ASSIGNED TO A-RINGE 2 AND VISA VERSA, E.G., THE RESULT OF TUBE 1 ON A-RING 1 IS ASSIGNED TO THE ID OF TUBE 1 ON A-RING 2, ETC. DEPENDING WHETHER A RUN WITH 1 OR 2 A-RINGS IS PERFORMED AND DEPENDING HOW CONTROLS AND SAMPLES ARE PLACED ON THE TWO A-RINGS, IT MIGHT NOT BE POSSIBLE TO DETECT THE WRONGFUL ASSIGNMENT OF THE RESULTS. THE COBAS AMPLICOR ANALYZER AND THE TC UNIT ARE MANUFACTURED FOR ROCHE MOLECULAR SYSTEMS, INC. AT THE ROCHE INSTRUMENT CENTER LOCATED IN ROTKREUZ, SWITZERLAND. THE COBAS AMPLICOR ANALYZER IS DISTRIBTUED BY ROCHE DIAGNOSTICS CORPORATION, INDIANAPOLIS, INDIANA. THE ANALYZER WAS 510(K) CLEARED IN MAY 1997 AS A CLASS 1 DEVICE.