LACTATE DEHYDROGENASE (LDH)

Additional Manufacturer Narrative

THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

Additional Manufacturer Narrative

H6: COMPONENT CODE: G01003. THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE ISSUE APPEARS TO BE SAMPLE SPECIFIC FOR CERTAIN PATIENT SAMPLES WHEN THE CUSTOMER USES GREINER TUBES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LIST NUMBER AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE (LDH) REAGENT WAS IDENTIFIED.

Additional Manufacturer Narrative

(B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. 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 LACTATE DEHYDROGENASE RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE SAMPLES. NO SPECIFIC PATIENT INFORMATION OR DATA OR COMPARISON DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.