LDL-CHOLESTEROL GEN.3

Additional Manufacturer Narrative

A REAGENT ISSUE IS NOT LIKELY SINCE CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE MAIN WATER PUMP PRESSURE WAS DETERMINED TO BE HIGH, BUT IS NOT LIKELY TO CAUSE THE ISSUE. A REVIEW OF ALARM TRACE DATA SHOWED ASPIRATION AND ABNORMAL BLANK ALARMS, WHICH ARE INDICATORS OF POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER CHECKED THE RINSE UNIT WATER LEVEL ADJUSTMENT, THE RINSE TUBE CONDITION, AND PROBE ADJUSTMENTS. THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LDL-CHOLESTEROL GEN. 3 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN LDL VALUE OF 5.00 MMOL/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED, RESULTING IN AN LDL VALUE OF 5.10 MMOL/L WITH A DATA FLAG. THESE VALUES WERE HELD AND NOT RELEASED TO THE PATIENT. THE SAMPLE WAS REPEATED AGAIN, RESULTING IN AN LDL VALUE OF 1.49 MMOL/L WHICH WAS THEN RELEASED TO THE PATIENT. THE SAMPLE WAS REPEATED AFTERWARDS AND RESULTED IN A VALUE OF 5.07 MMOL/L WITH A DATA FLAG. AN AMENDED REPORT WAS ISSUED.