COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 SYSTEM

Additional Manufacturer Narrative

A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME AS THE COMPLAINT INVESTIGATION IS ONGOING. HOWEVER, AS INDICATED WITHIN THE PRODUCT LABELING (CLINICAL PERFORMANCE DATA), OF THE (B)(6) THAT WERE TESTED, (B)(6) OF THESE SPECIMENS WERE (B)(6) WITH THE COBAS(R) TAQSCREEN MPX TEST. THESE DATA INDICATE THAT A CERTAIN PERCENTAGE OF (B)(6) DONOR SAMPLES WILL BE NON-REACTIVE WITH THE COBAS(R) TAQSCREEN MPX TEST. THE CENTERS FOR DISEASE CONTROL AND PREVENTION, (B)(6), PROVIDES THE FOLLOWING REFERENCE FOR INTERPRETATION OF (B)(6). THEREFORE, BASED ON THE CLINICAL PERFORMANCE DATA WITHIN THE PRODUCT LABELING, AND ON THE INTERPRETATION OF (B)(6) PROVIDED BY THE CDC, TESTS RESULTS OF RIBA + AND (B)(6) - CAN BE EXPECTED WHEN TESTING A DONOR/PATIENT SPECIMEN FOR THE (B)(6). CURRENTLY, ROCHE MOLECULAR SYSTEMS IS TRYING TO OBTAIN THE DONOR SAMPLE THAT GENERATED A (B)(6). INVESTIGATION CONCLUSIONS WILL BE SUBMITTED THROUGH A FOLLOW-UP REPORT. (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THAT A DONOR SAMPLE GENERATED A (B)(6) WHEN TESTED WITH THE COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201. THE CUSTOMER INDICATED THAT THE DONOR SAMPLE WAS (B)(6). BOTH THE COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 TEST RESULT AND THE RIBA TEST RESULT WERE REPORTED TO THE BLOOD CENTER. BASED ON BOTH TEST RESULTS, THE BLOOD CENTER DESIGNATED THE DONOR MATERIAL AS (B)(6) AND THE DONOR MATERIAL WAS NOT RELEASED INTO THE BLOOD SUPPLY. IT WAS INDICATED THAT THE DONOR SAMPLE WAS FROM A LIVING DONOR, BUT NO ADDITIONAL INFORMATION ABOUT THE DONOR WAS PROVIDED/AVAILABLE.