LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2019-00014. THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED. THIS REPORT WAS GENERATED TO DOCUMENT (B)(6) AS THE MANUFACTURE LOCATION. 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 A FALSELY ELEVATED LACTATE DEHYGROGENASE (LDH) RESULT WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER INDICATED THE PATIENT WAS ADMITTED AFTER THE INITIAL RESULT WAS GENERATED. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL 1154, RETEST RESULTS: 214, 209 AND 215 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. INSTRUMENT LOG FILE REVIEW DID NOT IDENTIFY AN INSTRUMENT ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE NO PRODUCT DEFICIENCY OF THE CLINICAL CHEMISTRY LACTATE DEHYDRGENASE ASSAY, REAGENT LIST NUMBER 02P56, LOT NUMBER 73199UN18, WAS IDENTIFIED.