COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD
Received Jun 28, 2019 · Event occurred May 8, 2019
Report 2243471-2019-00025 · MDR key 8744215
Device
Generic name
Assay, Hyb And/or Nucleic Acid Amp For Detection Of Hcv Rna, Hiv Rna
Manufacturer
Roche Molecular SystemsModel number
NACatalog number
05969492190
Lot number
303115
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
25 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ALTHOUGH THE SAMPLE IN QUESTION WAS REQUESTED FOR FURTHER INVESTIGATION, IT WAS NOT PROVIDED. THROUGH THE COURSE OF THE INVESTIGATION, WHICH INCLUDED REVIEW OF QC KIT RELEASE DATA AND INTERNAL NON-CONFORMANCES, NO PRODUCT ISSUE WAS IDENTIFIED. BASED ON THE TOTALITY OF THE INFORMATION PROVIDED THE QUESTIONED RESULT COULD BE DUE TO PRIMER-PROBE MISMATCHES DUE TO A MUTATION WITHIN THE AMPLIFIED REGION OF THE GENOME OR A DONATION WITH A HIV TITER BELOW THE LIMIT OF DETECTION (LOD) OF THE ASSAY. (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION INTO THIS ISSUE IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE UDI FOR THE COBAS TAQSCREEN MPX TEST, V2.0, US-IVD IS (B)(4). THE CORRESPONDING US KIT MATERIAL NUMBER IS 05969484190. (B)(4).
Description of Event or Problem
A CUSTOMER IN MEXICO REPORTED THE GENERATION OF FALSE NON REACTIVE COBAS TAQSCREEN MPX TEST, V2.0 RESULTS FOR ONE DONOR, WHEN COMPARED TO THE POSITIVE ELISA, WESTERN BLOT, AND TIGRIS NAT RESULTS. THE BLOOD DONATION WAS REJECTED.