(B)(4). NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. UPON INVESTIGATION THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR P11990 WAS REVIEWED AND THE ISSUE OF DISCREPANT RESULTS HAS NOT BEEN OBSERVED. THERE HAVE NOT BEEN ANY MANUFACTURING NON-CONFORMANCE REPORTS FOR BATCH P11990. RETAIN TESTING OF THE COMPLAINT BATCH P01607 WAS TESTED FOR THIS CASE AND GENERATED VALID AND ACCEPTABLE RESULTS. THE CUSTOMER RETURNED PANEL WAS SENT FOR SEQUENCING ANALYSIS. SEQUENCING ANALYSIS INDICATED THE FOLLOWING: - THE SAMPLE WAS DETERMINED TO BE SCC-MEC-RIGHT-EXTREMITY (RE) JUNCTION TYPE RE4. - THE RE4 SEQUENCE THAT WAS OBTAINED LACKS A LIGHTCYCLER (B)(6) ADVANCED TEST UPSTREAM PRIMER BINDING SITE, AND THEREFORE CANNOT BE AMPLIFIED. - THIS IS THE LIKELY CAUSE OF THE (B)(6) RESULTS FOR THIS SAMPLE BY THE (B)(6) ADVANCED TEST. THE LIGHT CYCLER (B)(6) ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT PACKAGE INSERT (M/N (B)(4)) INDICATES IN THE EXTERNAL POSITIVE CONTROL (EPC) SECTION THAT "(B)(6) STRAINS REPRESENTING RIGHT EXTREMITY (RE) JUNCTION 3 AND RE7 TYPES, IF AVAILABLE MAY BE USED AS ADDITIONAL EXTERNAL POSITIVE CONTROLS TO MONITOR ASSAY PRIMERS AND PROBES NOT DIRECTLY CONTROLLED IN THE ASSAY."ALSO, THE PACKAGE INSERT INDICATES THAT "THE RE TYPES THAT HAVE BEEN SHOWN TO BE DETECTED BY THE LIGHTCYCLER (B)(6) TEST INCLUDE RE2, RE3, AND RE7." (B)(4).
D
Patient 1
A CUSTOMER IN (B)(6) FILED A COMPLAINT ALLEGING THAT A (B)(6) RESULT WAS GENERATED WHEN USING THE LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 CE-IVD (M/N 05352894190; BATCH P11990). SPECIFICALLY, THE CUSTOMER STATED THAT THEY RAN A USER DEFINED CONTROLLED, WHICH WAS KNOWN TO CONTAIN THE (B)(6), HOWEVER, (B)(6) RESULTS WERE GENERATED WITH THE LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 CE-IVD (M/N 05352894190; BATCH P11990).
N
Patient 1
NO CONCLUSION CAN BE DRAWN AT THIS TIME AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE CONCLUSION OF THE INVESTIGATION WILL BE SUBMITTED THROUGH A FOLLOW-UP REPORT. THE ASSOCIATED US PRODUCT IS M/N 05205727190, K091409. (B)(4).