ALINITY C LACTATE DEHYDROGENASE REAGENT KIT

Additional Manufacturer Narrative

A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LDH REAGENT LOT 53885UN20. REVIEW OF TRACKING AND TRENDING REPORTS DID NOT IDENTIFY ANY RELATED TRENDS FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE PATIENT SAMPLE WAS RETESTED ON THE SAME INSTRUMENT AND ANOTHER ALINITY WITH ACCEPTABLE RESULTS GENERATED. FILE SAMPLE TESTING WAS NOT PERFORMED AS THE ORIGINAL SAMPLE GENERATED CORRECT RESULTS UPON RETESTING. 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 ALINITY C LACTATE DEHYDROGENASE (LDH) REAGENT, LOT NUMBER 53885UN20 WAS IDENTIFIED.

Additional Manufacturer Narrative

PATIENT IDENTIFIER: MULTIPLE (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 STATED THAT A PHYSICIAN QUESTIONED FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE ( (B)(4)) RESULTS ON ONE PATIENT. THE RESULTS OBTAINED FROM THE SAMPLES FROM THE SAME PATIENT COLLECTED ON (B)(6) 2020 WERE: SID (B)(6) 215.5 U/L, 212.1 U/L, 210.1 U/L; SID (B)(6) 243.1 U/L, 565.5 U/L, 226.0 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.