A CUSTOMER FROM THE (B)(6) FILED A COMPLAINT ALLEGING THAT (B)(6) RESULTS WERE GENERATED FOR ONE PATIENT SPECIMEN IN THREE SEPARATE RUNS WHEN USING THE COBAS 4800 HPV TEST WITH THREE DIFFERENT KIT LOTS (R15771, R16114, S01192). THE CUSTOMER WAS USING THE PREVIOUSLY TESTED (B)(6) PATIENT SPECIMEN AS AN EXTERNAL (B)(6) CONTROL AND SOME OF THE TARGETS TESTED (B)(6) IN THE THREE RUNS. MDR 2243471-2013-00040 IS BEING FILED FOR THE RESULTS GENERATED WITH COBAS HPV TEST LOT R15771. MDR 2243471-2013-00041 IS BEING FILED FOR THE RESULTS GENERATED WITH COBAS HPV TEST LOT R16114. MDR 2243471-2013-00042 IS BEING FILED FOR THE RESULTS GENERATED WITH COBAS HPV TEST LOT S01192
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Patient 1
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).
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Patient 1
(B)(4). THE COMPLAINT ALLEGED DISCREPANT (B)(6) RESULTS WERE GENERATED FOR ONE PATIENT SPECIMEN WHEN USING THE COBAS 4800 HPV TEST. THE CUSTOMER WAS USING THE PREVIOUSLY TESTED (B)(6) PATIENT SPECIMEN AS AN EXTERNAL NEGATIVE CONTROL AND IT TESTED (B)(6) ON A SUBSEQUENT RUN. THE CUSTOMER SELECTED THE SAMPLE RANDOMLY AS AN INTERNAL NEGATIVE CONTROL AS PER THE CERVICAL SCREENING GUIDELINES IN THE (B)(6). ALTHOUGH REQUESTED, THE INITIAL RUNS FOR THE ALLEGED SAMPLE IN WHICH THE SAMPLE TESTED NEGATIVE WERE NOT AVAILABLE FOR CT COMPARISON. AS THE 'INTERNAL NEGATIVE CONTROL', USED DURING THE CUSTOMER'S RUNS ARE SELECTED AT RANDOM, THE CUSTOMER HAS ADMITTED THAT IT IS POSSIBLE THAT THE INCORRECT SAMPLE WAS SELECTED FOR THIS SUBSEQUENT RUN. THE CUSTOMER USES A MANUAL SAMPLE ORDERING SYSTEM; THEY DO NOT GIVE THESE PARTICULAR SAMPLE A UNIQUE IDENTIFIERS THEREFORE THERE IS NO WAY OF CHECKING IF THE CORRECT SAMPLE WAS USED AS THE 'INTERNAL NEGATIVE CONTROL'. IT IS NOT RECOMMENDED TO USE PREVIOUSLY TESTED PATIENT SAMPLES AS 'INTERNAL NEGATIVE CONTROLS' AS RESULT DISCREPANCIES MAY BE GENERATED IF THE SAMPLE (S) CONTAIN A CONCENTRATION OF VIRUS NEAR THE LIMIT OF DETECTION OF THE TEST; ADDITIONALLY, THE COBAS 4800 HPV TEST REQUIRES AND HAS BEEN VALIDATED TO USE THE TEST'S NEGATIVE CONTROL. RETAIN TESTING OF THE COMPLAINT KIT MET SPECIFICATION. THE SAMPLE IN QUESTION IS NO LONGER AVAILABLE FOR INVESTIGATIVE TESTING. THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE. (B)(4).