LACTATE DEHYDROGENASE ACC. IFCC VER.2

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). QUALITY CONTROL DATA SHOWED IMPRECISION. UPON REVIEW OF ALARM TRACE DATA, ABNORMAL ASPIRATION AND SAMPLE SHORT ALARMS WERE OBSERVED. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE CUSTOMER REPLACED THE SAMPLE PROBE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LACTATE DEHYDROGENASE ACC. IFCC VER.2 ON A COBAS C 503 ANALYTICAL UNIT. A LITHIUM HEPARIN TUBE OF THE SAMPLE RESULTED IN AN LDH VALUE OF 270 U/L. A SECOND LITHIUM HEPARIN TUBE COLLECTED FROM THE PATIENT AT THE SAME TIME RESULTED IN AN LDH VALUE OF 608 U/L.

Additional Manufacturer Narrative

CALIBRATION DATA WAS ACCEPTABLE. THE SAMPLE CENTRIFUGATION WAS NOT PERFORMED AS RECOMMENDED BY THE TUBE MANUFACTURER. LITHIUM HEPARIN PLASMA TUBES WERE USED BY THE CUSTOMER. PER PRODUCT LABELING: "CAUTION: PLASMA FROM PRIMARY TUBES HANDLED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS CAN STILL CONTAIN CELLS, LEADING TO IMPLAUSIBLY HIGH RESULTS. ALTERNATIVELY, IT IS RECOMMENDED TO TRANSFER THE PLASMA FROM THE PRIMARY TUBE TO A SECONDARY SAMPLE TUBE.". THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.