ARCHITECT B12
Received Aug 14, 2019 · Event occurred Jun 12, 2018
Report 3005094123-2019-00224 · MDR key 8893750
Device
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PATIENT INFORMATION: PATIENT IDENTIFIER = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K61-35 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K61-37. TICKET SEARCHES FOR LOT 85398UI00 IDENTIFIED NORMAL COMPLAINT ACTIVITY. COMPLAINT TRENDING REPORTS WERE REVIEWED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THE COMPLAINT ISSUE. USING WORLDWIDE FIELD DATA THE HISTORICAL PERFORMANCE IN THE FIELD OF LOT 85398UI00 WAS REVIEWED. THE PATIENT MEDIAN RESULT FOR THE LOT WAS WITHIN ESTABLISHED LIMITS AND COMPARABLE TO OTHER REAGENT LOTS IN THE FIELD. MANUFACTURING DOCUMENTATION FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT B12 ASSAY WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSE ELEVATED ARCHITECT B12 RESULT FOR 1 PATIENT. SAMPLE ID (B)(6), (B)(6) 2018 INITIAL RESULT = 1070 PMOL/L (1449.9 PG/ML) THE SAMPLE WAS RETEST (DATE UNKNOWN) AND GENERATED 161 PMOL/L (218.2 PG/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.