LACTATE DEHYDROGENASE (LDH)

Additional Manufacturer Narrative

AN INVESTIGATION WAS PERFORMED FOR LACTATE DEHYDROGENASE (LDH) LIST NUMBER 2P56-22 LOT 44858UN21. A REVIEW OF TICKETS WAS PERFORMED AND FOUND NO OTHER TICKETS WITH THE SAME ERRATIC RESULTS ISSUE FOR THE REAGENT LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE (LDH) LIST NUMBER 2P56-22 LOT 44858UN21 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER IDENTIFIED FALSELY ELEVATED LACTATE DEHYDROGENASE RESULTS. THE CUSTOMER USES THE REFERENCE RANGE 125U/L TO 243 U/L. THE FOLLOWING INFORMATION WAS PROVIDED: SAMPLE 1 INITIAL RESULT 218 U/L, REPEATED 349 U/L. SAMPLE 2 INITIAL RESULT 606 U/L, REPEATED 838 U/L. THE CUSTOMER NOTED THAT THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND HAVE NOT BEEN QUESTIONED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

NO IDENTIFIER OR PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.