LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT NUMBER 1415939-2017-00093. THE MANUFACTURER LOCATION WAS INCORRECTLY DOCUMENTED. THIS REPORT IS BEING FILED. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, INHOUSE TESTING, INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURNED MATERIAL WAS AVAILABLE BUT NOT RETURNED. THE ASSAY FILES WERE SUCCESSFULLY CALIBRATED AND EACH VALIDITY CONTROL REPLICATE GENERATED WAS WITHIN THE ESTABLISHED RANGES DEMONSTRATING THE REAGENT LOT IS PERFORMING WITHIN SPECIFICATION. A REVIEW OF THE INSTRUMENT LOGS CONFIRMED THAT AN ERROR CODE WAS GENERATED DURING THE TIMEFRAME THE CUSTOMER GENERATED THE DISCREPANT RESULT. THIS ERROR COULD INDICATE THE PRESENCE OF BUBBLES, FOAM, OR FIBRIN IN THE SAMPLE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE CLINICAL CHEMISTRY LACTATE DEHYDROGENASE (LDH) ASSAY,LN 02P56, LOT NUMBER 47146UN15, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYGROGENASE (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: PATIENT 1: (NO SID PROVIDED) INITIAL 121, RETEST 93 SID: (B)(6), INITIAL 641, RETEST 279 AND 315, SID: (B)(6), INITIAL 1286, RETEST 279 AND 219, SID: (B)(6), INITIAL 636, RETEST 251 AND 251. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.