TINA-QUANT C-REACTIVE PROTEIN I

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 111 ANALYZER IS (B)(6). THE CUSTOMER NOTED THAT CARRYOVER EVASION WASHES ON THE ANALYZER WERE ONLY CONFIGURED FOR THE CHOLESTEROL TEST. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT C-REACTIVE PROTEIN I ON A COBAS C 111 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 335.6 MG/L. THE REAGENT PACK WAS NEARLY DEPLETED AT THE TIME OF MEASUREMENT. A NEW REAGENT PACK WAS LOADED AND THE SAMPLE WAS REPEATED TWICE, RESULTING IN CRP VALUES OF 28.14 MG/L AND 28.29 MG/L.

Additional Manufacturer Narrative

THE CUSTOMER WAS NOT USING CHIMNEYS ON THE REAGENT PACKS. ACCORDING TO THE METHOD SHEET: "UNDER CONDITIONS OF EXTREME HUMIDITY, CONDENSATION MAY LEAD TO A DILUTION OF THE REAGENT THAT AFFECTS THE MEASUREMENTS. HENCE UNDER ENVIRONMENTAL CONDITIONS IN WHICH TEMPERATURE AND HUMIDITY ARE EQUAL TO, OR IN EXCESS OF 25 °C/80 %, 28 °C/70 %, 30 °C/60 % OR 32 °C/55 % A CHIMNEY (CAT. NO. 11930630001) SHOULD BE USED TO REDUCE THE CONDENSATION RATE. PLACE A WHITE CHIMNEY IN R1 AND A BLACK CHIMNEY IN SR." THE CUSTOMER CONFIRMED THAT CARRYOVER EVASION WASHES FOR OTHER TEST PARAMETERS WERE NOT PROGRAMMED ON THE ANALYZER. CONTROL RESULTS BEFORE THE EVENT WERE FLAGGED AS OUT OF RANGE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH A FAILURE OF THE INDIVIDUAL REAGENT PACK THAT WAS IN USE AT THE TIME. A GENERAL REAGENT ISSUE CAN BE EXCLUDED.