ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

A REVIEW OF TICKETS WAS PERFORMED FOR ALINITY I B12 REAGENT LOT 25094UD00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE REAGENT LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A RETAINED REAGENT KIT OF LOT NUMBER 25094UD00 WAS TESTED. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 REAGENT LOT 25094UD00 WAS IDENTIFIED.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.

Description of Event or Problem

THE CUSTOMER GENERATED DISCREPANT ALINITY I B12 RESULTS FOR 3 PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: SAMPLE SID (B)(6): 245, 244, 239, 280, 253, 256, 236, 238, 259 PMOL/L SAMPLE SID (B)(6): 202, 188, 172, 185, 180, 220, 186, 182, 171, 224 PMOL/L SAMPLE SID (B)(6): 124, <109, 116, <109, 122, 134, <109, 111, 143, 131, PMOL/L THE CUSTOMER IS UNCERTAIN AS TO WHAT THE CORRECT RESULT SHOULD BE FOR EACH PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

(B)(4) WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO MULTIPLE SIDS INVOLVED IN THIS EVENT; (B)(6). NO PATIENT DEMOGRAPHIC INFORMATION IS AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS EVENT IS BEING REPORTED FOR INTERNATIONAL LIST NUMBER 07P67-32, WHICH IS SIMILAR TO THE US LIST NUMBER 7P67-31 ALINITY I B12.