LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2

Additional Manufacturer Narrative

THE FOLLOWING 2 STATEMENTS IN PRODUCT LABELING APPLY TO THE CUSTOMER'S ISSUE: CONTAMINATION WITH ERYTHROCYTES WILL ELEVATE RESULTS, BECAUSE THE ANALYTE LEVEL IN ERYTHROCYTES IS HIGHER THAN IN NORMAL SERA. THE LEVEL OF INTERFERENCE MAY BE VARIABLE DEPENDING ON THE CONTENT OF ANALYTE IN THE LYSED ERYTHROCYTES. PLASMA FROM PRIMARY TUBES HANDLED ACCORDING TO THE MANUFACTURER¿S INSTRUCTION CAN STILL CONTAIN CELLS, LEADING TO IMPLAUSIBLY HIGH RESULTS. CELL DEBRIS AT THE TOP OF THE SAMPLE LEADING TO THE PHENOMENON DESCRIBED IN PRODUCT LABELING IS THE MOST REASONABLE ROOT CAUSE FOR THE ISSUE. THE FOLLOWING MEDWATCH FIELDS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 (LDH) ON A COBAS C 111 (C111). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 221 U/L. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER OF UNKNOWN TYPE AT A DIFFERENT LABORATORY AND THE RESULT WAS 119 U/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE LDH REAGENT LOT NUMBER WAS 197423. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.