LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2017-00132. THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED IN THE ORIGINAL REPORT. THIS REPORT WAS GENERATED TO DOCUMENT (B)(4) AS THE MANUFACTURE LOCATION. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, AN INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE INSTRUMENT LOG REVIEW INDICATED THAT THE ANALYZER HAD GENERATED ERROR CODES TO INDICATE THAT ASPIRATION ERRORS HAD OCCURRED. ADDITIONALLY, IT INDICATED THAT PREVENTATIVE MAINTENANCE WAS NOT PERFORMED (CLEAN CUVETTES) IN (B)(6) 2017. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR ISSUE OBSERVED BY THE CUSTOMER. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED WITH THIS REAGENT LOT NUMBER. 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 80712UN16, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: INITIAL 1046, THIS RESULT WAS QUESTIONED BY THE PHYSICIAN AND TESTING WAS REPEATED RETESTS: 187 AND 192. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.