Description of Event or Problem · 1
APPROXIMATELY 5 YEARS AGO, BIO-RAD LABORATORIES TRANSITIONED CUSTOMERS FROM THE PREVIOUSLY LICENSED GENETIC SYSTEMS HIV-1/ HIV-2 EIA KIT, CATALOG # 0230, TO THE CURRENT GENETIC SYSTEMS HIV- 1/HIV-2 PEPTIDE EIA KIT, CATALOG # 32551. THIS PARTICULAR CUSTOMER, VERIFIED AS HAVING THE GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE ELA VALIDATION PROTOCOL ON THEIR COMPUTER, CONTINUED TO USE THE OUTDATED GENETIC SYSTEMS HIV-1/ HIV-2 EIA MICROPLATE ASSAY TESTING SYSTEM (MAS) VALIDATION PROTOCOL WITH THE GENETIC SYSTEMS HIV-1/ HIV-2 PEPTIDE EJA KIT. MAS IS A 510(K)-CLEARED SOFTWARE PRODUCT USED TO CALCULATE RESULTS FOR EIA TEST KITS. THE CUSTOMER WAS ABLE TO BYPASS THE LOT VALIDATION/SECURITY FEATURE IN THE MAS SOFTWARE BY INTENTIONALLY ENTERING THE WRONG LOT NUMBER (FOR EXAMPLE, LOT 199VP1 WOULD BE ENTERED BY THE CUSTOMER AS 199VR1). THE CO DOES NOT UNDERSTAND WHY THE CUSTOMER DECIDED TO ENTER THE INCORRECT LOT NUMBERS RATHER THAN CONTACTING BIO-RAD TECHNICAL SUPPORT FOR ASSISTANCE. WITH THE GENETIC SYSTEMS HIV-1/HIV-2 EIA VALIDATION PROTOCOL VERSION 1.30, THE HIV-1/ HIV-2 EIA HAS A CUTOFF CALCULATION OF NC + 0.250. WITH THE GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE ETA VALIDATION PROTOCOL VERSION 2.02, THE HIV-1/HIV-2 PEPTIDE EIA HAS A CUT OFF CALCULATION OF NC + 0.240. USING THE WRONG VALIDATION PROTOCOL RESULTS IN A DIFFERENCE OF 0.010 IN THE CUT OFF CALCULATION WHERE BORDERLINE REACTIVE RESULTS MAY HAVE BEEN IDENTIFIED AS NON-REACTIVE. THE CO HAS INSTRUCTED THE CUSTOMER TO CEASE RUNNING ALL ASSAYS ON THE GENETIC SYSTEMS HIV-1/HIV-2 VALIDATION PROTOCOL VERSION 1.30 AND TO USE THE CURRENT VALIDATION PROTOCOL GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA VERSION 2.02 AS PROGRAMMED IN THEIR LAB'S COMPUTER. A BIO-RAD FIELD SERVICE REPRESENTATIVE REMOVED THE COMPUTER FROM THE CUSTOMER'S SITE. BIO-RAD LABORATORIES TECHNICAL SUPPORT REVIEWED THE HIV-1/HIV-2 PEPTIDE EIA ASSAY DATA STORED ON THIS COMPUTER. THIS DATA SPANNED THE DATES OF 1997 THROUGH 2002 (SEE SECTION B6 FOR RESULTS OF THIS REVIEW). THE CUSTOMER ALSO STATED THAT THEY MIGHT NOT HAVE STORED THE DATA IN MAS FOR ALL ASSAY RUNS PERFORMED. THE CO RECOMMENDED THAT THEY REVIEW ALL ASSAY DATA GENERATED WITH THE OUTDATED MICROPLATE ASSAY TESTING SYSTEM (MAS) VERSION 4.81, ASSAY VALIDATION DRIVER (AVD) VERSION 4.82, VALIDATION PROTOCOL VERSION 1.30. THIS WOULD INCLUDE ASSAY RUNS FROM 4/2002 UP UNTIL THE DATE THEY BEGAN USING THE CORRECT PROTOCOL, AS WELL AS ANY RUNS TESTED BEFORE THAT TIME, WHICH WERE NOT SAVED IN THEIR COMPUTER. THE CO RECOMMENDS RETESTING ANY PATIENT WHOSE RESULTS WERE LESS THAN OR EQUAL TO 0.010 BELOW THE CUTOFF, AS THESE SAMPLES MAY HAVE YIELDED A REACTIVE RESULT HAD THEY BEEN TESTED USING THE GENETIC SYSTEMS HIV-1/HIV-2 PEPTIDE EIA VALIDATION PROTOCOL. A NEW COMPUTER WITH ONLY THE CURRENT VALIDATION PROTOCOLS WAS INSTALLED AT THE CUSTOMER SITE ON 11/19/02.