ACCESS HLH

Additional Manufacturer Narrative

A1: THE FULL PATIENT IDENTIFIER IS CASE (B)(4). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. D4 AND H4: NO REAGENT LOT NUMBER WAS PROVIDED. NO UDI. NO EXPIRATION DATE. DEVICE MANUFACTURE DATE INDICATED AS 02AUG2021 (INSTRUMENT MANUFACTURE DATE) AS NO REAGENT ACCESS HLH LOT NUMBER WAS PROVIDED BY THE CUSTOMER. H3 AND H6:A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE SAMPLE WAS TESTED ON THE ROCHE PLATFORM AND ASUS PLATFORM, RESULTS WERE 0.2 IU/L. THE BEC INITIAL RESULT WAS DIFFERENT WITH THE THIRD-PARTY PLATFORM. THE LSS SUSPECTED THE SAMPLE MAY HAVE INTERFERENCE, SO PERFORMED A PEG (POLYETHYLENE GLYCOL PRECIPITATION) TESTING ON THE INITIAL SAMPLE AND ACCESS HLH RESULT DECREASED TO 0.01IU/L, WHICH WAS CONSISTENT WITH THE THIRD-PLATFORM RESULTS. THE LSS COMMUNICATED TO CUSTOMER THAT THE CAUSE OF THE ELEVATED HLH RESULTS MAY BE DUE TO THE PRESENCE OF INTERFERING SUBSTANCES. HOWEVER THE PEG TESTING METHOD USED WAS NOT VALIDATED. THE PRESENCE OF INTERFERENCE CANNOT BE CONFIRMED. PER THE ACCESS HLH INSTRUCTIONS FOR USE C64666 F, IT STATES ¿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. AND ¿THE ACCESS HLH 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¿. IN CONCLUSION, ALTHOUGH INTERFERENCE IS SUSPECTED, IT COULD NOT BE VERIFIED AS NO SAMPLE WAS TESTED WITH AN APPROVED METHODOLOGY. THE ASSIGNABLE CAUSE FOR THIS ISSUE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS EVIDENCE OF A MALFUNCTION AS ORIGINAL RESULT IS DISCORDANT TO THE DIFFERENT METHODOLOGY AND THE PATIENT'S CLINICAL FILE.

Description of Event or Problem

CUSTOMER REPORTED REPEATABLE FALSE HIGH ACCESS HLH FROM (PART NUMBER 33510) PATIENT RESULTS ON THEIR ACCESS2 ANALYZER (SERIAL NUMBER (B)(6). THE CUSTOMER STATED THAT THE SAMPLE INITIAL RESULT WAS 0.85IU/L, THE CUSTOMER RETESTED THE SAMPLE AND RESULT WAS 0.8IU/L(CUSTOMER EXPECTED VALUE: <0.2IU/L), THE CLINICAL SUSPECTED THAT THE PATIENT HAS CENTRAL PRECOCIOUS PUBERTY, SO THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A GNRH STIMULATION TEST AND THE RESULT SHOWED NEGATIVE. SO, THE CUSTOMER QUESTIONED THE BEC INITIAL LH RESULT. NO HARDWARE ERRORS AND OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT, SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION, AND QUALITY CONTROL (QC) AT THE TIME OF THE EVENT WERE NOT PROVIDED FOR REVIEW. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. A BECKMAN COULTER LSS (LABORATORY SOLUTION SPECIALIST) WAS DISPATCHED TO CUSTOMER SITE.