LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2020-00096, FOR WHICH AN ERROR WAS IDENTIFIED WITH THE MANUFACTURER NAME (ABBOTT GMBH) AND AN INCORRECT LIST NUMBER (02P56-42). THIS MDR IS BEING SUBMITTED TO CORRECT THE MANUFACTURER NAME TO ABBOTT LABORATORIES (IRVING/ATM) AND TO CORRECT THE LIST NUMBER FROM 02P56-42 TO 02P56-21. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF TRENDING DATA, AND A REVIEW OF PRODUCT LABELING. TICKET SEARCHES DID NOT IDENTIFY ANY OTHER COMPLAINTS SIMILAR TO THE CURRENT COMPLAINT ISSUE. NO TRENDS WERE IDENTIFIED. NO OTHER ISSUES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT WHEN PROCESSING ON THE ARCHITECT C16000. THE INITIAL RESULT WAS 514 U/L AND RETEST WAS 198 U/L. RETESTING ON ANOTHER INSTRUMENT YIELDED RESULTS OF 195, 7, AND 197 U/L. THE CUSTOMER USES A REFERENCE RANGE OF 125-220 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.