LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, AN INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, DESIGN HISTORY RECORD (DHR) REVIEW, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR ISSUE OBSERVED BY THE CUSTOMER. THE DHR REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. 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 99549UN18, WAS IDENTIFIED.

Additional Manufacturer Narrative

(B)(6) 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 (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS FOR 2 PATIENTS (REFERENCE RANGE 125 TO 220 U/L): PATIENT 1: INITIAL 303, RETESTS: 238, 218, 300 AND 295 U/L. PATIENT 2: INITIAL 349, RETESTS: 214, 205 AND 206. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

ON JANUARY 8, 2019 IT WAS IDENTIFIED THAT: THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED UNDER THIS MANUFACTURER REPORT NUMBER (1415939-2018-00152). A NEW MANUFACTURER REPORT (NUMBER 1628664-2019-00040) HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.