TINA-QUANT C-REACTIVE PROTEIN IV

Additional Manufacturer Narrative

THE COBAS 6000 C501 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION RESULTS HAD DATA FLAGS. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE ALARM TRACE CONTAINED SAMPLE PROBE ERRORS. THE MODULE HAS BEEN DEINSTALLED, AND FURTHER INVESTIGATION WAS NOT POSSIBLE. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 0.40 MG/L WITH A DATA FLAG. THE REPEAT RESULT WAS 149.85 MG/L. THE REPEAT RESULT WAS DEEMED CORRECT.