CLNICAL CHEMISTRY LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS WHILE USING CLINICAL CHEMISTRY LACTATE DEHYDROGENASE (LDH) REAGENTS. THE FOLLOWING DATA WAS PROVIDED. THE CUSTOMER USES RANGE 10 TO 1500 U/L. SID (B)(6) INITIAL 505 U/L, REPEAT 238 U/L. NO TREATMENT WAS GIVEN BASED ON THE INITIAL RESULT AND NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, AN INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, BATCH RECORD REVIEW, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. NO ISSUES WERE IDENTIFIED WHICH WOULD INDICATE A PRODUCT DEFICIENCY FROM THE BATCH RECORD REVIEW. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR ISSUE OBSERVED BY THE CUSTOMER. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO DEFICIENCY OF THE CLINICAL CHEMISTRY LDH ASSAY, REAGENT LIST NUMBER 02P56, LOT 12577UN18, WAS IDENTIFIED.