LACTATE DEHYDROGENASE (LDH)

Additional Manufacturer Narrative

CORRECTED INFORMATION CAN BE FOUND IN SECTION D4 CATALOGUE NUMBER, CHANGED FROM 02P56-21 TO 02P56-22.

Additional Manufacturer Narrative

A SEARCH BY LOT NUMBER DID NOT FIND ELEVATED COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH LOT 81714UN21 AND THE COMPLAINT ISSUE. THE CUSTOMER FOUND FOAM IN THE BOTTLE AND DETERMINED THAT WAS THE LIKELY CAUSE FOR ELEVATED RESULTS. AS PART OF TROUBLESHOOTING, THE R2 BOTTLE WAS REPLACED, THE SAMPLE WAS RETESTED, AND RESULTS OBTAINED WERE WITHIN RANGE. LABELING WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CC LDH REAGENT LOT 81714UN21 WAS IDENTIFIED.CORRECTED DATA FOUND IN SECTION G1.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 125 TO 243 U/L): SID (B)(6) INITIAL RESULT WAS 893 U/L, NO REPEAT RESULT PROVIDED. SID (B)(6) INITIAL RESULT WAS 872 U/L, NO REPEAT RESULT PROVIDED. SID (B)(6) INITIAL RESULT WAS 905 U/L, NO REPEAT RESULT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

PATIENT IDENTIFIER: MULTIPLE = SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.