NA ELECTRODE

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 303 ANALYZER IS (B)(6) . THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS C 303 ANALYTICAL UNIT. SAMPLE 1 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE AND CL ELECTRODE. THIS MEDWATCH WILL APPLY TO THE NA ELECTRODE. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE CL ELECTRODE. SAMPLE 1 ALSO HAD DISCREPANT RESULTS WHEN TESTED WITH THE ELECSYS TROPONIN T GEN 5 ON A COBAS PURE E 402 ANALYTICAL UNIT. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE TROPONIN T ASSAY. SAMPLE 2 HAD DISCREPANT RESULTS WHEN TESTED WITH THE NA ELECTRODE, K ELECTRODE, CL ELECTRODE, AND CALCIUM GEN.2. THIS MEDWATCH WILL APPLY TO THE NA ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE K ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE CL ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE CALCIUM ASSAY. A PHYSICIAN QUESTIONED THE INITIAL SAMPLE VALUES SO THE SAMPLES WERE REPEATED. NEITHER THE INITIAL OR REPEAT VALUES WERE DEEMED CORRECT, SO THE PATIENTS WERE RE-DRAWN AND RE-TESTED. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A NA VALUE OF 120 MMOL/L AND IT REPEATED AS 140 MMOL/L. THIS SAMPLE INITIALLY RESULTED IN A CL VALUE OF 85 MMOL/L AND IT REPEATED AS 99.6 MMOL/L. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN A NA VALUE OF 87 MMOL/L AND IT REPEATED AS 144.5 MMOL/L. THIS SAMPLE INITIALLY RESULTED IN A K VALUE OF 2.63 MMOL/L AND IT REPEATED AS 4.16 MMOL/L. THIS SAMPLE INITIALLY RESULTED IN A CL VALUE OF 60.5 MMOL/L AND IT REPEATED AS 105.95 MMOL/L. THIS SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 5.74 MG/DL AND IT REPEATED AS 9.72 MG/DL.

Additional Manufacturer Narrative

THE CUSTOMER STATED THAT QC RECOVERY HAS BEEN ACCEPTABLE AND STABLE. THE CUSTOMER SUSPECTS THERE WAS A SAMPLE HANDLING ISSUE RELATED TO HOW THEY ARE PREPARING THEIR FROZEN SAMPLES. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.