COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD

Additional Manufacturer Narrative

AN (B)(6) CUSTOMER ALLEGED THE GENERATION OF A (B)(6) RESULT WITH THE COBAS TAQSCREEN MPX TEST V2.0 CE-IVD (LOT 225191) FOR A DONOR SAMPLE, WHEN TESTED IN A POOL OF 1. THE DONOR SAMPLE GENERATED (B)(6) SEROLOGY RESULTS FOR (B)(6) AND UPON REPEAT TESTING WITH THE COBAS TAQSCREEN MPX TEST V2.0 CE-IVD (LOT 225191), AN (B)(6) REACTIVE RESULT WAS OBTAINED. THE BLOOD ASSOCIATED WITH THIS DONOR WAS DISCARDED AND NO HARM WAS ALLEGED. THROUGH THE COURSE OF THE INVESTIGATION, SAMPLE WAS REQUESTED FROM THE CUSTOMER FOR FURTHER TESTING; HOWEVER, AS THE BLOOD WAS DISCARDED THERE WAS NO ADDITIONAL SAMPLE LEFT. THE RETAIN KIT LOT (225191) WAS TESTED AND MET SPECIFICATIONS; NO (B)(6) RESULTS WERE GENERATED. NO KIT ISSUES WERE IDENTIFIED IN THE REVIEW OF THE QC KIT RELEASE DATA GENERATED FOR THIS LOT, AND THERE WERE NO RELATED INTERNAL NON-CONFORMANCES. POSSIBLE ISSUES THAT COULD LEAD TO NO AMPLIFICATION OF TARGETS OR SUPPRESSION OF THE IC INCLUDE WORK FLOW ISSUES DURING SAMPLE PREP, DUST, CONTAMINATION OR OTHER PCR INHIBITORS (E.G. HEPARIN, DNA AWAY). THE UDI FOR THE COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD IS (B)(4). THE CORRESPONDING US KIT MATERIAL NUMBER IS (B)(4). (B)(4).

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED A RESULT DISCREPANCY DURING USE OF THE MPXV2 ASSAY. ON (B)(6) 2017 THE CUSTOMER TESTED A PP6 WHICH GENERATED A (B)(6) RESULT FOR (B)(6) (CT.23.2). RESOLUTION POOLING (RESP1) WAS PERFORMED ON (B)(6) 2017 AND ALL SAMPLES IN THE POOL GENERATED (B)(6) RESULTS. DUE TO THE FACT THAT SEROLOGY WAS (B)(6) FOR THE DONOR, ON (B)(6) 2017, A NEW ALIQUOT (FROM THE SAME WITHDRAWAL) WAS TESTED IN PP1.