LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

THE FIELD APPLICATION SPECIALIST PERFORMED CALIBRATION AND REPEATED THE PATIENT COMPARISONS USING REAGENT LOTS 747707 AND 773098. THE COMPARISON WAS ACCEPTABLE. THE ANALYZER ALARM TRACE CONTAINED MULTIPLE ALARMS INDICATING ISSUES WITH SAMPLE QUALITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENATE (LDHI GEN.2) RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE CUSTOMER WAS SWITCHING TO A NEW LOT OF REAGENT AND PERFORMED A PATIENT COMPARISON. THE SAMPLES WERE REPEATED ON ANOTHER COBAS 6000 C 501 USING NEW REAGENT LOT 747707. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. PATIENT 1 INITIAL RESULT WAS 377 U/L AND THE REPEAT RESULT WAS 245 U/L. PATIENT 2 INITIAL RESULT WAS 260 U/L AND THE REPEAT RESULT WAS 153 U/L. PATIENT 3 INITIAL RESULT WAS 390 U/L AND THE REPEAT RESULT WAS 245 U/L. PATIENT 4 INITIAL RESULT WAS 262 U/L AND THE REPEAT RESULT WAS 153 U/L.

Additional Manufacturer Narrative

THE COBAS 6000 C 501 ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.