ACCESS GI MONITOR

Description of Event or Problem

THE CUSTOMER REPORTED FALSE ACCESS HIGH GI MONITOR (CA 199) (PART NUMBER 387687) RESULT FOR ONE PATIENT ON THEIR DXI800 ANALYZER (PART 973100 SERIAL NUMBER (B)(6). THE 9-YEAR-OLD MALE PATIENT INITIALLY CAME TO THE HOSPITAL FOR AN EXAMINATION DUE TO EXPERIENCING ABNORMAL WEIGHT LOSS, WHICH, ACCORDING TO CUSTOMER FEEDBACK, AMOUNTED TO A LOSS OF OVER TEN POUNDS WITHIN A THREE-MONTH PERIOD. ON MAY 10TH, THE CLINIC SIMULTANEOUSLY ORDERED A COMPLETE BLOOD COUNT, CA 19.9, COMPUTED TOMOGRAPHY (CT), AND OTHER EXAMINATIONS. THE CT SCAN RESULTS INDICATED A SIGNIFICANT ACCUMULATION OF GAS WITHIN THE ABDOMINAL INTESTINAL CAVITY. THE RESULT OF CA 19.9 WAS 364.41 U/ML (REFERENCE RANGE =25 U/ML). THE CLINIC DID NOT PROCEED WITH FURTHER EXAMINATIONS OR PRESCRIBE ANY MEDICATION FOR THE PATIENT. ON MAY 11TH, THE PATIENT WENT TO ANOTHER HOSPITAL TO TEST ON THE ABBOTT PLATFORM, AND THE RESULT WAS 4.5 U/ML (REFERENCE RANGE 0-37 U/ML). ON MAY 21ST, THE PATIENT INDEPENDENTLY WENT TO ANOTHER HOSPITAL. AT THAT TIME, A COMPLETE BLOOD COUNT AND OTHER TESTS, AS WELL AS A CA19-9 TEST, WERE CONDUCTED. THE CA19-9 RESULTS SHOWED NORMAL LEVELS. ACCORDING TO THE CLIENT'S DESCRIPTION, A FULL ABDOMINAL CT SCAN WAS ALSO PERFORMED AT THAT TIME, AND THE RESULTS DID NOT REVEAL ANY SIGNIFICANT ABNORMALITIES. THE PATIENT COMPLAINED ABOUT BECKMAN'S HIGH CA199 VALUE RESULT, WHICH LED TO THE PATIENT UNDERGOING MANY UNNECESSARY TESTS, AND IS DEMANDING COMPENSATION. NO HARDWARE ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QC (QUALITY CONTROL) AT THE TIME OF THE EVENT WERE NOT PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THE DEALER ENGINEER WAS DISPATCHED TO THE CUSTOMER'S SITE.

Additional Manufacturer Narrative

A1: THE FULL IDENTIFIER FOR THIS REPORT IS (B)(4). A2AND A3: THE PATIENT IS A 9-YEAR-OLD MALE. A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. H3 AND H6: THE DEALER ENGINEER WAS DISPATCHED TO THE CUSTOMER'S SITE. THE DEALER ENGINEER RETESTED THE INITIAL PATIENT SAMPLE ON ROCHE PLATFORMS FROM TWO DIFFERENT HOSPITALS AND THE RESULTS WERE AT 32.6 U/ML AND 31.2 U/ML (REFERENCE RANGE 0-34 U/ML) WHICH WERE WITHIN RANGES. THE ENGINEER ALSO RETESTED THE INITIAL PATIENT SAMPLE ON MINDRAY PLATFORM, AND THE RESULT WAS SLIGHTLY HIGH, BUT CLOSE TO THE NORMAL VALUE. THE CUSTOMER CONSIDERED THAT THE ROCHE RESULTS BETTER ALIGNED WITH CLINICAL REQUIREMENTS. THE ENGINEER ALSO CONDUCTED PEG SEDIMENTATION EXPERIMENTS AND DILUTION TESTS AND THE RESULTS WERE ALL ELEVATED. THE CUSTOMER SUSPECTED INTERFERENCE IN THE SAMPLE AND REQUESTED INTERFERENCE TESTING. AN INTERFERENCE TESTING, USING DIFFERENT BLOCKERS, WAS THEN CARRIED OUT ON DXI 800 ANALYZER. THE BLOCKER USED IN THE INTERFERENCE TESTING CONSIST OF MOUSE, HBR-1, POLY-MAK, GOAT IGG AND BOVINE IGGS WHICH ARE ANIMAL DERIVED ANTIBODIES. A POOL OF BLOCKERS RELATED TO ALKALINE PHOSPHATASE (AP MUTEIN, SCAVENGER ALP) WAS ALSO TESTED. IT WAS FOUND THAT THE ELEVATED RESULT COULD NOT BE DECREASED BY ADDING ALL BLOCKERS. PER THE GI MONITOR INSTRUCTIONS FOR USE (IFU), PAR NUMBER (PN) C64664 F, IT STATES: THE ACCESS GI MONITOR RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HAMA, THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN-PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES. THIS ASSAY IS SUSCEPTIBLE TO INTERFERENCE FROM HIGH LEVELS OF BIOTIN. THE RECOMMENDED DAILY INTAKE FOR BIOTIN IS 30 ¿G. HIGH DOSES OF BIOTIN (UP TO 30 MG PER DAY) MAY BE TAKEN AS A DIETARY SUPPLEMENT AIMED AT IMPROVING HAIR LOSS, NAIL GROWTH, OR SKIN CONDITION. THE ENGINEER INFORMED THE CUSTOMER ABOUT THE VARIABILITY OF INTERFERING SUBSTANCES AND THE INHERENT LIMITATIONS OF THE DETECTION METHOD. IN CONCLUSION, ALTHOUGH INTERFERENCE IS SUSPECTED, INTERFERENCE TESTING DID NOT CONFIRM THE PRESENCE OF ANY INTERFERENCE. AN ASSIGNABLE CAUSE FOR THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS A DISCORDANT MALFUNCTION AS ORIGINAL RESULT IS DISCORDANT WITH REPLICATE MEASUREMENTS ON ABBOTT AND ROCHE DEVICES. NOTE: NO ACCESS GI MONITOR REAGENT LOT NUMBER WAS PROVIDED: NO UDI, NO EXPIRATION OR MANUFACTURING DATES COULD BE PROVIDED (SECTION D4) AND FOR SECTION H4: THE DEVICE MANUFACTURE DATE IS RELATED TO THE ANALYZER AS NO INFORMATION RELATED TO THE REAGENT WAS PROVIDED.