TINA-QUANT C-REACTIVE PROTEIN IV

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) PERFORMED EXTENSIVE HARDWARE MAINTENANCE, INCLUDING REPLACING REAGENT ARMS, PRINTED CIRCUIT BOARDS, GEAR PUMPS, AND PHOTOMETER MAINTENANCE, BUT NO DEFINITIVE HARDWARE FAILURE WAS LINKED TO THE EVENT. THE FSE THEN RELOADED THE REAGENT CASSETTE AND TESTED PATIENT SAMPLES, AND THE RESULTS WERE ACCURATE. THE PHYSICAL ACT OF RELOADING THE REAGENT CASSETTE WAS CONSISTENT WITH CLEARING THE AIR BUBBLE OR REDISTRIBUTING THE SETTLED PARTICLES, WHICH RESOLVED THE ISSUE. AFTER THE HARDWARE MAINTENANCE AND THE RELOADING OF THE REAGENT CASSETTE, THE FSE VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE CAUSE OF THE EVENT WAS CONSISTENT WITH INADEQUATE MIXING OR IMPROPER STORAGE/TRANSPORT TEMPERATURES OF THE REAGENT. ALL REAGENT CASSETTES NEED TO BE PROPERLY INVERTED/MIXED BEFORE LOADING.

Additional Manufacturer Narrative

A CONFIRMATION WAS RECEIVED ABOUT THE RESULTS FOR 1 PATIENT SAMPLE THAT WAS PROVIDED IN MEDWATCH FIELD B5 (DESCRIBE EVENT OR PROBLEM): SHOULD BE: "INITIAL RESULT: >350 MG/L (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 589 MG/L (TESTED IN A DECREASED MODE). 2ND REPEAT RESULT: 213 MG/L." INSTEAD OF: "INITIAL RESULT: >350 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 1ST REPEAT RESULT: 510 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 2ND REPEAT RESULT: 307 MG/L. 3RD REPEAT RESULT: 220 MG/L. A CONFIRMATION ABOUT THE REPEAT RESULTS OF 307 MG/L AND 220 MG/L WAS REQUESTED, BUT HAS NOT BEEN PROVIDED YET." THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR SEVERAL PATIENTS' SAMPLES TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ASSAY ON A COBAS C 503 ANALYTICAL UNIT. INITIAL RESULT: >350 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 1ST REPEAT RESULT: 510 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 2ND REPEAT RESULT: "HALF LOWER" (TESTED WITH ANOTHER REAGENT CASSETTE). NO EXACT VALUE WAS PROVIDED. DISCREPANT RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED: INITIAL RESULT: >350 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 1ST REPEAT RESULT: 510 MG/L (TESTED WITH THE CURRENT REAGENT CASSETTE). 2ND REPEAT RESULT: 307 MG/L. 3RD REPEAT RESULT: 220 MG/L. A CONFIRMATION ABOUT THE REPEAT RESULTS OF 307 MG/L AND 220 MG/L WAS REQUESTED, BUT HAS NOT BEEN PROVIDED YET.