COBAS AMPLIPREP / COBAS TAQMAN HCV, US-IVD
Received Sep 16, 2011 · Event occurred Mar 1, 2011
Report 2243471-2010-00085 · MDR key 2250575
Device
Generic name
Assay, Hybridization, Nucleic Acid Amplification, Detection Of Hcv Rna
Manufacturer
Roche Molecular SystemsCatalog number
03568555190
Lot number
N15292
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4): CONCLUSION - UNABLE TO CONFIRM COMPLAINT.THE CUSTOMER ALLEGED THAT THE PATIENT SAMPLE FROM (B)(4) 2011 WAS UNDER-QUANTITATED WITH THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST, US IVD (CAP/CTM HCV) WHEN COMPARED TO THE TEST RESULTS GENERATED WITH THE GEN-PROBE HCV QNT TMA ASSAY AND THE VERSANT BDNA ASSAY. ALTHOUGH REQUESTED, THE CUSTOMER DID NOT PROVIDE ANY DATA, KIT BATCH INFORMATION OR CLINICAL SAMPLE MATERIAL TO PERFORM THE INVESTIGATION. THEREFORE, IT CANNOT BE DETERMINED WHETHER THE SAMPLE WAS INCORRECTLY QUANTIFIED. (B)(4).
Description of Event or Problem
A CUSTOMER SITE IN THE US ALLEGED THAT TWO PATIENT SAMPLES WERE (B)(6) WITH THE (B)(6) TEST, US IVD ((B)(6)) WHEN COMPARED TO THE TEST RESULTS GENERATED WITH THE GEN-PROBE (B)(6) ASSAY AND THE (B)(6) ASSAY. THIS REPORT IS FOR THE SAMPLE RESULT GENERATED IN (B)(6) 2011. MDR 2243471-2011-00086 IS FILED FOR THE SAMPLE RESULT GENERATED IN (B)(6) 2011.
Additional Manufacturer Narrative
A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).