Description of Event or Problem · 1
ON (B)(6), 2015, THE CUSTOMER CONTACTED BIO-RAD LABORATORIES TECHNICAL SERVICES TO REPORT CONFLICTING (B)(6) RESULTS ON A PATIENT. THE (B)(6) PATIENT WAS BEING TESTED FOR (B)(6) DUE TO A HISTORY OF RECURRENT PNEUMONIA OVER THE PAST YEAR. THE PATIENT ALSO HAS DOWN'S SYNDROME. FIRST THE SAMPLE WAS SCREENED ON ABBOTT ARCHITECT 4TH GENERATION ASSAY AND THE RESULT WAS REPEAT REACTIVE. NEXT, ON (B)(6) 2015, THE SAMPLE WAS RUN ON THE GEENIUS HIV 1/2 SUPPLEMENTAL ASSAY WITH THE RESULT OF (B)(6). THE SAMPLE WAS ALSO RUN ON THE SIEMEN CENTAUR 3RD GENERATION ASSAY AND THE ALLERE HIV 1/2 ANTIGEN ANTIBODY RAPID TEST WITH THE RESULTS OF (B)(6), RESPECTIVELY. THE SAMPLE WAS RERUN ON THE ABBOTT ARCHITECT WITH THE RESULT OF (B)(6). A NEW SAMPLE WAS OBTAINED FROM THE PATIENT. THE NEW SAMPLE WAS RUN ON THE ABBOTT ARCHITECT WITH THE RESULT OF REPEAT REACTIVE. NEXT, ON (B)(6) 2015, THE NEW SAMPLE WAS RUN ON GEENIUS HIV 1/2 SUPPLEMENTAL ASSAY WITH THE RESULTS OF (B)(6). THE SAMPLE WAS SENT FOR A WESTERN BLOT AND THE RESULTS WERE INDETERMINATE DUE TO THE BAND PATTERN BEING UNREADABLE. THE NAT TEST OF THIS SAMPLE SHOWED LESS THAN 20 COPIES (B)(6). THE CUSTOMER SENT BIO-RAD LABORATORIES 150 UL OF THE (B)(6) 2015 DRAW. THE SAMPLE TESTED REACTIVE ON (B)(6) COMBO WITH A S/CO OF 1.407. THE SAMPLE TESTED INVALID ON TWO LOTS OF THE MULTISPOT HIV-1/HIV-2 RAPID TEST DUE TO HALO COLORATION AROUND ALL SPOTS. THE HALO COLORATION IS DUE TO A NON-SPECIFIC REACTION BY SOME SAMPLES CAUSING THE MULTISPOT CARTRIDGE TO BECOME UNREADABLE AND INVALID. WHEN SAMPLES PRODUCE THIS REACTION, THE CUSTOMER IS ADVISED TO PERFORM FURTHER TESTING. THE SAMPLE TESTED (B)(6) ON THE GEENIUS[?] HIV 1/2 SUPPLEMENTAL ASSAY. A LETTER WAS WRITTEN TO THE CUSTOMER WITH THE DETAILS OF THE PRODUCT SUPPORT TESTING PERFORMED AT BIO-RAD LABORATORIES. THE CUSTOMER WAS ADVISED THAT THEY ARE NOT REPORTABLE SINCE THEY WERE NOT PERFORMED IN A LICENSED CLINICAL LABORATORY. BIO-RAD LABORATORIES LEARNED THAT THE PATIENT WAS HOSPITALIZED. AFTER INQUIRING WHY THE PATIENT WAS HOSPITALIZED, ON (B)(6) 2015 BIO-RAD LABORATORIES RECEIVED AN EMAIL STATING THAT THE PATIENT'S PATHOLOGIST SPOKE TO THE INFECTIOUS DISEASE PHYSICIAN WHO EXAMINED THE PATIENT. THE INFECTIOUS DISEASE PHYSICIAN TOLD THE PATHOLOGIST THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE RESULTS OF THE (B)(6) TESTING. THE PATIENT WAS NEVER TREATED FOR (B)(6) INFECTION PRIOR TO THE HOSPITALIZATION, DURING THE HOSPITALIZATION, OR AFTER DISCHARGE. ULTIMATELY, THE PATHOLOGIST DIAGNOSED THE PATIENT AS (B)(6). WHILE BIO-RAD HAS NOT BEEN ABLE TO OBTAIN ADDITIONAL TESTING OR RESULTS, DUE TO THE DISCREPANCY OF 4TH GENERATION TEST (ABBOTT ARCHITECT AND GEENIUS HIV 1/2 SUPPLEMENTAL ASSAY) RESULTS VERSUS OTHER TESTING METHODS AND THE HOSPITALIZATION OF THE PATIENT, A MDR IS BEING FILED FOR THIS CASE. NOTE: ALTHOUGH THE PATIENT WAS HOSPITALIZED, NO TREATMENT OCCURRED.