ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

THE INVESTIGATION IN STILL IN-PROCESS. A FOLLOW-UP WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. 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

THE COMPLAINT INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, ATTACHED DATA, TRENDING DATA, LABELLING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE TICKET SEARCHES DETERMINED NORMAL COMPLAINT ACTIVITY FOR LOT 23159UI00. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH LOT 23159UI00 AND THE COMPLAINT ISSUE. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN HOUSE TESTING WAS COMPLETED USING RETAINED SAMPLES OF THE COMPLAINT LOT 23159UI00. THE TESTING MET ALL ACCEPTANCE CRITERIA. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 REAGENT LOT 23159UI00 WAS IDENTIFIED.

Additional Manufacturer Narrative

WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. INITIAL REPORTER EMAIL: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS WHEN COMPARED TO OTHER INSTRUMENTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL B12 RESULTS (AI03961) 335 PG/ML RETESTED ON ANOTHER INSTRUMENT (AI03969) 376 PG/ML / 390 PG/ML . RETESTED AT A DIFFERENT LAB AND THE RESULTS WERE 254 - 282 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.