PHOS2

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH PHOS2 (PHOSPHORUS) ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A PHOSPHORUS VALUE OF 0.9 MG/DL. DUE TO THE VALUE BEING LOW, THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 9.5 MG/DL. THE SAMPLE WAS REPEATED SEVERAL TIMES, BUT NOT ADDITIONAL VALUES WERE PROVIDED. THE 0.9 MG/DL VALUE WAS DEEMED CORRECT.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C702 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE CUSTOMER INDICATED THEY DID NOT RECEIVE ANY ALARMS. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE. NO ISSUES WERE OBSERVED WITH REACTION CELL WASHING, PROBE WASHING, OR PROBE ADJUSTMENTS. NO ISSUES WERE OBSERVED WITH CALIBRATION OR CONTROLS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL ISSUES.