FDA.reportPublic FDA data

MAUDE MDR 8421208

MDR report key
8421208
Report number
1219913-2019-00033
Event key
0
Event type
3
Date of event
2019-02-14
Date received
2019-03-14
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. EIMAN SULIEMAN
Address
333 CONEY STREET E. WALPOLE MA 02032 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVIA CENTAUR XP CEA ASSAYCEA IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.DHXN/A10309977178R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-140

Event Narratives#

N

Patient 1

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. NO MECHANICAL ISSUES IDENTIFIED. THE CUSTOMER HAD PLACED SAMPLES ON FOR CEA TESTING SUBSEQUENT TO THIS ISSUE A FEW DAYS LATER. THE ISSUE APPEARS TO HAVE BEEN AN ISOLATED EVENT. THE INITIAL ISSUE WAS REPORTED AS CEA LOT 178, DISCORDANT PATIENT RESULTS. THE CUSTOMER SERVICE ENGINEER (CSE) REVIEWED THE ISSUE AND RESULTS WITH THE CUSTOMER. THEY DETERMINED THAT THIS ISSUE OCCURRED WITHIN A CONFINED TIME PERIOD TOWARD THE END OF THE RUN ON (B)(6) 2019. THEY REVIEWED THE RUNS FROM THAT DAY AND DAYS BEFORE AND AFTER AND COULD FIND NO OTHER DISCORDANT RESULTS. THEY REVIEWED THE EVENT LOGS AS WELL AS CALIBRATION AND QUALITY CONTROL (QC) RESULTS WITH ALL RESULTS IN RANGE AND ACCEPTABLE. THEY PERFORMED CALIBRATION AND QC TO VERIFY SYSTEM PERFORMANCE WITH ALL RESULTS IN RANGE. WHILE THE ISSUE MAY HAVE BEEN RELATED TO REAGENT OR SAMPLE PREPARATION, THE CAUSE COULD NOT BE DETERMINED. NO FURTHER ISSUES WERE REPORTED. THE INSTRUCTION FOR USE (IFU) IN THE INTERPRETATION OF RESULTS SECTION STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) IN THE LIMITATIONS SECTION STATES: "WARNING DO NOT USE THE ADVIA CENTAUR CEA IMMUNOASSAY AS A SCREENING TEST FOR DIAGNOSIS. NOTE DO NOT INTERPRET LEVELS OF CEA AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. MEASUREMENTS OF CEA SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION. THE CONCENTRATION OF CEA IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. CEA DETERMINED WITH DIFFERENT MANUFACTURERS' ASSAYS WILL VARY DEPENDING ON THE METHOD OF STANDARDIZATION AND ANTIBODY SPECIFICITY."

D

Patient 1

A FALSE HIGH ADVIA CENTAUR XP CEA RESULT WAS OBTAINED ON A PATIENT SAMPLE (B)(6). THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PHYSICIAN THOUGHT THE RESULT SHOULD BE LOWER. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. THE LOWER RESULT WAS REPORTED. THE CUSTOMER DECIDED TO REPEAT APPROXIMATELY NINE OTHER SAMPLES THAT WERE RUN AROUND THE SAME TIME THAT PATIENT WAS ON (B)(6) 2019 ON THE SAME ADVIA CENTAUR XP. THE REPEAT RESULTS FOR (4) SAMPLES WERE LOWER. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER DECIDED TO FURTHER REVIEW ALL CEA RESULTS FROM (B)(6) 2019 AND IDENTIFIED 179 TESTS FOR CEA WERE PROCESSED THAT DAY. APPROXIMATELY 50 RESULTS WERE FROM AROUND THE TIME FRAME OF (B)(6). THE CUSTOMER PERFORMED REPEAT TESTING WITH AVAILABLE SAMPLES ON ANOTHER ADVIA CENTAUR XP IN THE LABORATORY. FOURTEEN CORRECTED REPORTS WERE SENT TO THE PHYSICIAN. THE CUSTOMER WAS NOT ABLE TO REPEAT ALL QUESTIONABLE RESULTS BECAUSE SAMPLES WERE NO LONGER AVAILABLE. THEY CONTACTED THE PHYSICIANS AND INFORMED THEM OF THE DISCORDANT RESULTS AND RECOMMENDED PATIENTS BE REDRAWN FOR REPEAT TESTING. ADDITIONAL SAMPLE DATA FOR THESE RESULTS WAS NOT PROVIDED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.