LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

CORRECTION TO SECTION D. SUSPECT MEDICAL DEVICE WAS DISCOVERED ON (B)(6) 2020. THE CATALOG# WAS SUBMITTED AS 02P56-42 (WIESBADEN, GERMANY MANUFACTURING SITE) BUT SHOULD BE 02P56-21 (IRVING, TEXAS MANUFACTURING SITE). SEE MDR # 1628664-2020-00079 FOR THE CORRECT MANUFACTURING SITE.

Additional Manufacturer Narrative

(B)(4). 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, A REVIEW OF PRODUCT QUALITY HISTORY, AND A REVIEW OF PRODUCT LABELING. THE TICKET SEARCHES DETERMINED THERE WERE NO OTHER COMPLAINTS SIMILAR TO THE CURRENT COMPLAINT ISSUE AND THE TRACKING AND TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO RELATED TRENDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. 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 STATED THAT A FALSELY ELEVATED ARCHITECT LDH RESULT OF 337 U/L WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 151 U/L ON THE SAME ARCHITECT ANALYZER AND 132/136 U/L ON A DIFFERENT ARCHITECT ANALYZER. THE CUSTOMER'S NORMAL RANGE IS 125 TO 220 U/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.