ARCHITECT B12 REAGENT KIT

Additional Manufacturer Narrative

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 B12 RESULTS FOR MULTIPLE SAMPLES WHEN COMPARED TO A REFERENCE LABORATORY. ADDITIONALLY, THE CUSTOMER NOTED THERE WAS A SHIFT IN QC RESULTS STARTING ON (B)(6) 2022. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 211 TO 1074 PG/ML, TEST DATE WAS (B)(6) 2022, UNITS OF MEASURE IS PG/ML): SID (B)(6) ARCHITECT RESULT = 315, ARUP RESULT = 200. SAMPLE 5: ARCHITECT RESULT = 360, ARUP RESULT = 255. SAMPLE 6: ARCHITECT RESULT = 383, ARUP RESULT = 273. SAMPLE 10: ARCHITECT RESULT = 405, ARUP RESULT = 254. SAMPLE 14: ARCHITECT RESULT = 371, ARUP RESULT = 235. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT B12 RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW AND IN-HOUSE TESTING. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY LOT NUMBER 34043UD00 AND COMPLAINT ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH COMPLAINT LOT NUMBER 34043UD00. TESTING MET VALIDITY AND ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT B12 REAGENT FOR LOT 34043UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT B12 RESULTS FOR MULTIPLE SAMPLES WHEN COMPARED TO A REFERENCE LABORATORY. ADDITIONALLY, THE CUSTOMER NOTED THERE WAS A SHIFT IN QC RESULTS STARTING ON 03MAR2022. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 211 TO 1074 PG/ML, TEST DATE WAS (B)(6) 2022, UNITS OF MEASURE IS PG/ML): SID (B)(6) INITIAL RESULT = 315, ARUP RESULT = 200. SAMPLE 5: INITIAL RESULT = 360, ARUP RESULT = 255. SAMPLE 6: INITIAL RESULT = 383, ARUP RESULT = 273. SAMPLE 10: INITIAL RESULT = 405, ARUP RESULT = 254. SAMPLE 14: INITIAL RESULT = 371, ARUP RESULT = 235. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.