ATELLICA IM CA 19-9
Received Mar 11, 2025 · Event occurred Feb 15, 2025
Report 1219913-2025-00049 · MDR key 21576062
Device
Generic name
System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pa
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
N/ACatalog number
10995489
Lot number
24842543
Product problems
- High Test Results
- High Test Results
Patient
66 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTS AN ELEVATED ATELLICA IM CA19-9 RESULT WITH LOT: 543 ON ONE PATIENT SAMPLE. THE ELEVATED RESULT WAS CONSIDERED DISCORDANT RELATIVE TO A LOWER, HISTORICAL ALTERNATE CA19-9 METHOD RESULT AND THE PATIENT'S CLINICAL CONDITION. QUALITY CONTROL (QC) AND PROFICIENCY SAMPLES ARE WITHIN ACCEPTABLE RANGES. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.
Additional Manufacturer Narrative
SIEMENS INVESTIGATED AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER COMPLAINT OF AN ELEVATED ATELLICA IM CA 19-9¿ (CA 19-9¿) LOT: 543 PATIENT RESULT. THE ELEVATED RESULT WAS CONSIDERED DISCORDANT RELATIVE TO A LOWER, HISTORICAL ALTERNATE CA19-9 METHOD RESULT AND THE PATIENT'S CLINICAL CONDITION. THE INVESTIGATION INCLUDED AN ASSESSMENT OF CUSTOMER CALIBRATION, QUALITY CONTROL (QC), AND PATIENT DATA. REAGENT PERFORMANCE ISSUES WERE RULED OUT BASED ON QC RESULTS, WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES. THERE WERE NO ISSUES REPORTED WITH OTHER PATIENT SAMPLES. THE SAMPLE IN QUESTION WAS TESTED WITH AN ALTERNATE CA 19-9 METHOD; AN ELEVATED RESULT WAS OBTAINED. HETEROPHILIC BINDING TUBE (HBT) TREATMENT AND TESTING OF THE SAMPLE AT THE CUSTOMER SITE DID NOT GENERATE A LOWER/NORMAL RESULT. RESULT >700 U/ML. THE CUSTOMER INDICATED THAT THE PATIENT WAS TAKING ZOLEDEX (GOSERELIN); THE POTENTIAL INTERFERENCE OF THIS DRUG WITH THE ATELLICA IM CA 19-9 WAS RULED OUT BY SIEMENS R&D AS THIS IS A SYNTHETIC PEPTIDE. THERE IS NOTHING FROM A STRUCTURAL STANDPOINT SUGGESTING THAT IT WOULD INTERFERE WITH THE ASSAY. THE RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT POSSIBLE AS SAMPLE VOLUME IS INSUFFICIENT. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE ELEVATED ATELLICA IM CA 19-9 RESULT FOR THIS SAMPLE CANNOT BE DETERMINED BUT APPEARS TO BE A PATIENT SPECIFIC ISSUE. CUSTOMER HAS NOT HAD ANY SIMILAR ISSUES. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING.