LACTATE DEHYDROGEN

Additional Manufacturer Narrative

ON MARCH 22, 2019 IT WAS IDENTIFIED THAT: THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED UNDER THIS MANUFACTURER REPORT NUMBER (1415939-2017-00050). A NEW MANUFACTURER REPORT (NUMBER 1628664-2019-00246) HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

Additional Manufacturer Narrative

LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. IN HOUSE TESTING PROTOCOL WAS EXECUTED; THE ASSAY FILES FOR THE REAGENT LOT NUMBER WAS SUCCESSFULLY CALIBRATED AND EACH VALIDITY CONTROL REPLICATE GENERATED WAS WITHIN THE ESTABLISHED RANGES. IT WAS DETERMINED THE REAGENT LOT IS PERFORMING ACCEPTABLY. 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 DEHYDROGENASE ASSAY, REAGENT LIST NUMBER 02P56 , LOT NUMBER 47148UN15 , 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 FOR CHEMOTHERAPY PATIENT THAT IS PARTAKING IN A CLINICAL TRIAL. ADDITIONAL PATIENT RESULTS ARE IN QUESTION BUT NO ADDITIONAL RESULT DATA WAS PROVIDED. ON (B)(6) 2016 (PLASMA): INITIAL 431U/L, RETEST 298U/L, 196U/L. THE CUSTOMER IS CONCERNED THAT IF THE RESULTS STAY HIGH THE PATIENT MAY NEED TO END THEIR PARTICIPATION IN THE STUDY. HOWEVER, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.