COBAS MPX TEST, CE-IVD

Additional Manufacturer Narrative

NO ISSUES WERE IDENTIFIED WITH THE COMPLAINT KIT LOT DURING THE INVESTIGATION; THE COMPLAINT ALLEGATION WAS NOT OBSERVED DURING QC KIT RELEASE AND THERE ARE NO RELATED NON-CONFORMANCES. A (B)(6) SEROLOGY, (B)(6) SEROLOGY, AND DISCREPANT NAT RESULTS, COULD BE DUE TO A VIRAL LOAD NEAR OR AT THE LIMIT OF DETECTION (LOD) OF THE (B)(6) TEST (NAT) WHILE THE SURFACE ANTIGEN MAY HAVE DECREASED TO A NON-DETECTABLE LEVEL. CORE MAY STILL BE PRESENT AND DETECTED. AN OCCULT BLOOD INFECTION (OBI) SHARES THESE CHARACTERISTICS AND CAN BE A POSSIBLE CAUSE. IN ADDITION THE ONLY DISCREPANCY BETWEEN NAT WAS A (B)(6) POOL OF 6 AND A (B)(6) IDT (ARCHIVE SAMPLE). AS IN THE POOL OF 6 THE SAMPLE IS DILUTED IT IS LESS SENSITIVE THAN A IDT SAMPLE. OVERALL THERE IS NOT INDICATION OF A PRODUCT PROBLEM. SAMPLE IS NOT AVAILABLE FOR FURTHER INVESTIGATION. PER (B)(6), CE-IVD INSTRUCTIONS FOR USE: DETECTION OF (B)(6) IS DEPENDENT ON THE NUMBER OF VIRUS PARTICLES PRESENT IN THE SAMPLE AND MAY BE AFFECTED BY SAMPLE COLLECTION, STORAGE AND HANDLING, PATIENT FACTORS (I.E., AGE, PRESENCE OF SYMPTOMS), AND/OR STAGE OF INFECTION AND POOL SIZE. THE MATERIAL NUMBER FOR THE (B)(6) TEST, 96T, US-IVD IS 06998909190. THE UDI FOR THE (B)(6)TEST, 96T, US-IVD IS (B)(4). (B)(4).

Description of Event or Problem

A CUSTOMER IN LATVIA REPORTED THAT A REPEAT DONOR GENERATED (B)(6) RESULTS WITH THE (B)(6) TEST DURING RECENT TESTING (B)(6) 2020). (B)(6) RESULTS WERE GENERATED FOR THIS DONOR WHEN TESTED IN POOLS OF 6 (PP6) AND RESOLUTION POOL TESTING OF 1 (RESP1). SEROLOGY (B)(6) WAS (B)(6). BY REGULATIONS, THE CUSTOMER WAS OBLIGATED TO PERFORM A "LOOK-BACK" PROCEDURE TO FIND THE LAST (B)(6) DONATION GIVEN BY THE DONOR IN QUESTION. PREVIOUS DONATIONS FROM THE DONOR IN QUESTION (RED-CELL CONCENTRATES AND PLATELETS), FROM (B)(6) 2019, (B)(6) 2019 AND (B)(6) 2019, WERE TRANSFUSED TO RECIPIENTS AS THE DONOR GENERATED (B)(6) RESULTS IN PP6 DURING THOSE PREVIOUS TIMEPOINTS. ALL ARCHIVED SAMPLES OF THE PARTICULAR DONOR WERE PULLED AND TESTED WITH THE (B)(6) TEST, AND GENERATED (B)(6) RESULTS IN IDT (INDIVIDUAL TESTING). WHEN THESE SAMPLES WERE PREVIOUSLY TESTED ALL RESULTS WERE (B)(6) IN PP6 AND THE (B)(6) TEST RESULTS FOR ALL PREVIOUS DONATIONS WERE (B)(6). TO DATE, THERE IS NO INFORMATION ABOUT HARM/INJURY TO THE RECIPIENTS.