inforMED
MZP

KIT CAP-G/CTM HCV 48 TESTS VERSION 2

Received Aug 9, 2013 · Event occurred Jun 27, 2013

Report 2243471-2013-00023 · MDR key 3273479

Device

Generic name

Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hcv

Catalog number

05532264190

Lot number

111337

Product problems

  • Incorrect Or Inadequate Test Results

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT DISCREPANT RESULTS WERE GENERATED FOR THREE SAMPLES WHEN USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HCV TEST (V1) AND COBAS AMPLIPREP / COBAS TAQMAN HCV TEST, VERSION 2. THE TITERS GENERATED WERE SIGNIFICANTLY HIGHER WITH THE V1 TEST. ALL SAMPLES WERE TESTED ON (B)(6)2013. NO PATIENT INFORMATION WAS PROVIDED FOR ANY OF THE SAMPLES. THIS REPORT WILL ADDRESS THE RESULTS OBTAINED FOR SAMPLE (B)(4) USING THE CAP/CTM HCV TEST, VERSION 2. MDR 2243471-2013-00022 WILL ADDRESS THE RESULTS OBTAINED FOR SAMPLE (B)(4) USING THE CAP/CTM HCV TEST (V1).

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. THE ASSOCIATED US PRODUCT CODE IS 05480442190 P060030/27. (B)(4).

Additional Manufacturer Narrative

DATE ADDITIONAL INFORMATION WAS RECEIVED BY MANUFACTURER (05-SEP-2013). FOLLOW UP REPORT 1. ADDITIONAL EVALUATION / DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER: YES. (B)(4). A CUSTOMER FROM (B)(6) ALLEGED RESULT DISCREPANCIES FOR PATIENT SAMPLE (B)(6) BETWEEN THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST ("V1.0") AND THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST, V2.0. THE LOG10 DIFFERENCE IN TITERS FOR THIS PATIENT SAMPLE BETWEEN THE TWO ASSAYS WAS 0.65LOG10, WITH THE "V1.0" TEST GENERATING A HIGH TITER COMPARED TO THE V2.0 TEST. REVIEW OF THE V2.0 PRODUCT LABELING INDICATED THAT SOME (B)(6) GENOTYPES GENERATED HIGHER TITERS WITH THE "V1.0" TEST VERSUS THE V2.0 OF THE ASSAY. INVESTIGATIVE TESTING OF THE V2.0 RETAIN KIT GENERATED ACCEPTABLE RESULTS; RESULTS MET SPECIFICATIONS AND THERE WAS NO INDICATION OF A PRODUCT NON-CONFORMANCE. THE ROOT CAUSE FOR THE RESULT DISCREPANCIES COULD NOT IDENTIFIED AS THE PROBLEMATIC PATIENT SAMPLE WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION. THIS REPORT ADDRESSES THE RESULT OBTAINED FOR (B)(6) USING THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST, V2.0. REPORT # 224371-2013-00022 F1 ADDRESSES THE RESULT OBTAINED FOR (B)(6) USING THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST ("V1.0"). (B)(4)