COBAS TAQSCREEN MPX TEST

Additional Manufacturer Narrative

A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

Description of Event or Problem

A CUSTOMER IN THE US FILED A COMPLAINT ALLEGING THAT A DONOR SAMPLE GENERATED A (B)(6) RESULT WHEN USING THE COBAS TAQSCREEN MPX TEST, LOT R01528. SINGLE DONOR TESTING ON PLASMA FROM A LIVING DONOR GENERATED A (B)(6) WITH THE COBAS TAQSCREEN MPX TEST ON (B)(6) 2013. SEROLOGY TESTING WITH THE ABBOTT PRISM TEST GENERATED A (B)(6) RESULT ON (B)(6) 2013. THE COBAS AMPLISCREEN (B)(6) WAS THEN RUN ON (B)(6) 2013 AND GENERATED A (B)(6). IT IS CURRENTLY UNKNOWN IF THE BLOOD UNIT WAS RELEASED FOR DONATION.

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER GENERATED A NON-REACTIVE RESULT FOR A PLASMA LIVING DONOR SAMPLE TESTED WITH THE COBAS TAQSCREEN MPX TEST IN PRIMARY POOLS OF 96. THE SAMPLE WAS DETERMINE TO BE (B)(6) SEROLOGY (B)(6). A (B)(6) RESULT GENERATED WITH THE COBAS AMPLISCREEN (B)(6) TEST. THE DONOR SAMPLE IN QUESTION AND ASSOCIATED RAW DATA FILES, ALTHOUGH REQUESTED, WERE NOT AVAILABLE FOR INVESTIGATIVE TESTING. THE FALSE (B)(6) RESULT MAY BE DUE TO THE SAMPLE HAVING A LOW (B)(6) VIRAL LOAD TITER, AS THE SAMPLE WAS DILUTED DURING MPX TESTING WITHIN A PRIMARY POOL OF 96 OR POSSIBLY DUE TO A MUTATION WITHIN THE VIRAL SEQUENCE OF THE SAMPLE THAT PROHIBITED BINDING TO THE HIGHLY CONSERVED REGIONS OF THE VIRAL GENOME COBAS TAQSCREEN MPX TEST PRIMERS AND/OR PROBE. SINCE THE SAMPLE WAS NOT AVAILABLE FOR TESTING AND NO FURTHER INFORMATION WAS PROVIDED, THE TRUE CAUSE OF THE FALSE NON-REACTIVE RESULT COULD NOT BE DETERMINED. RETAIN KIT TESTING MET SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE. (B)(4).