ARCHITECT ACTIVE-B12 (HOLOTRANSCOBALAMIN) REAGENT KIT

Additional Manufacturer Narrative

(B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. 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 OBSERVED FALSELY ELEVATED ARCHITECT ACTIVE-B12 RESULTS GENERATED ON THE ARCHITECT I2000 INSTRUMENT FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL RESULT ON (B)(6) 2021= 63.4 PMOL/L, REPEATED ON (B)(6) 2021 48.9 PMOL/L. SID (B)(6) INITIAL RESULT =97.8 PMOL/L, REPEATED 71 PMOL/L. SID (B)(6) INITIAL RESULT = 35.2 PMOL/L, REPEATED 27.8 PMOL/L. SID (B)(6) INITIAL RESULT = 124.5 PMOL/L, REPEATED 95.5 PMOL/L. SID (B)(6) INITIAL RESULT = 117.8 PMOL/L, REPEATED 82.6 PMOL/L. SID (B)(6) INITIAL RESULT = 49.7 PMOL/L, REPEATED 35.4 PMOL/L. SID (B)(6) INITIAL RESULT = 94.1 PMOL/L, REPEATED 72.4 PMOL/L. SID (B)(6) INITIAL RESULT = 63.4 PMOL/L, REPEATED 46 PMOL/L. SID (B)(6) INITIAL RESULT = 43.9 PMOL/L, REPEATED 34.6 PMOL/L. SID (B)(6) INITIAL RESULT = 65.2 PMOL/L, REPEATED 50.2 PMOL/L. SID (B)(6) INITIAL RESULT = 58.5 PMOL/L, REPEATED 42.8 PMOL/L. SID (B)(6) INITIAL RESULT = 91.2 PMOL/L, REPEATED 60.1 PMOL/L. SID (B)(6) INITIAL RESULT = 75.8 PMOL/L, REPEATED 56.2 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A TICKET SEARCH FOR LOT 11098UP00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO FALSELY ELEVATED RESULTS. 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 11098UP00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. ACCURACY TESTING WAS ALSO PERFORMED TO EVALUATE THE PERFORMANCE OF REAGENT LOT 11098UP00. AN INTERNAL ACTIVE-B12 (HOLOTRANSCOBALAMIN) PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ACTIVE-B12 (HOLOTRANSCOBALAMIN) FOR LOT NUMBER 11098UP00 WAS IDENTIFIED.

Additional Manufacturer Narrative

THIS INVESTIGATION FOR THE REPORTED EVENT IS STILL ON-GOING.THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10.