InjuryLSL
APTIMA COMBO 2 ASSAY
Received Aug 7, 2019 · Event occurred Jul 9, 2019
Report 2024800-2019-00010 · MDR key 8872141
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
CUSTOMER IN (B)(6) IDENTIFIED DISCORDANT SAMPLES BETWEEN AC2 AND OTHER CT ASSAYS AND REQUESTED SEQUENCING RESULTS FOR 10 NEAT URINE SPECIMENS THAT WERE SENT TO HOLOGIC. ON (B)(6) 2019, SEQUENCING OF THE SPECIMENS WAS COMPLETED BY HOLOGIC. SEQUENCES WERE OBTAINED FROM 7 OF THE 10 SPECIMENS. THE PRESENCE OF A CT VARIANT WAS IDENTIFIED IN 6 OF THOSE SPECIMENS.