inforMED
MKZ

COBAS AMPLICOR CT/NG TEST

Received Oct 20, 2011 · Event occurred Sep 20, 2011

Report 2243471-2011-00093 · MDR key 2302659

Device

Generic name

Dna Probe, Nucleic Acid Amplification, Chlamydia

Catalog number

20759902122

Lot number

P02319

Product problems

  • Off-Label Use
  • Incorrect Or Inadequate Test Results

Patient

Not reported

  • No Information

Narrative

Description of Event or Problem

A CUSTOMER SITE IN (B)(6) ALLEGES THAT DISCREPANT RESULTS WERE GENERATED WITH THE COBAS AMPLICOR CT/NG TEST. THE CUSTOMER SITE REPEAT TESTED (B)(6) RESULTS, WHICH IS AN OFF-LABEL PRACTICE. AS PER PRODUCT LABELING, A (B)(6) RESULT SHOULD BE REPORTED. ROCHE DOES NOT RECOMMEND OR SUPPORT THE REPEATING OF (B)(6) RESULTS FOR THE ASSAY. PLEASE NOTE THAT THE COBAS AMPLICOR CT/NG DETECTION KIT ENCOMPASSES A NUMBER OF REAGENT KITS BELOW ARE THE KITS THAT ARE USED WITH THIS PRODUCT: KIT AMPL CT/NG PREP GEN2 100T IVD M/N 20759414122, KIT CA CT DET GEN 2 100 IVD M/N 20757497122, KIT CA NG DET 100 TESTS IVD M/N 20757535122.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE CUSTOMER ALLEGED THAT DISCREPANT RESULTS WERE GENERATED WITH THE COBAS AMPLICOR CT/NG TEST. THE CUSTOMER SITE REPEAT TESTED (B)(6) RESULTS, WHICH IS AN OFF-LABEL PRACTICE. AS PER PRODUCT LABELING, A VALID RESULT SHOULD BE REPORTED. ROCHE DOES NOT RECOMMEND OR SUPPORT THE REPEATING OF VALID (B)(6) RESULTS FOR THE ASSAY. ALTHOUGH REQUESTED, NO PATIENT SAMPLES WERE RETURNED FOR FURTHER INVESTIGATION. RETAIN TESTING WAS NOT PERFORMED AS NO TREND WAS IDENTIFIED. ADDITIONALLY, THE CUSTOMER ALLEGATION WAS NOT SEEN IN THE PRODUCT RELEASE DATA FOR THE COMPLAINT KIT LOT AND NO INTERNAL NON-CONFORMANCES WERE IDENTIFIED, INDICATING THAT THERE IS NO EVIDENCE OF A PRODUCT ISSUE ASSOCIATED WITH THE COMPLAINT KIT (B)(4).