MalfunctionLSL
COBAS PCR MEDIA DUAL SWAB SAMPLE KIT
Received Oct 15, 2018 · Event occurred Oct 10, 2018
Report 7964648 · MDR key 7964648
Device
Generic name
Dna-reagents, Neisseria
Manufacturer
Roche Molecular Systems, Inc.Model number
07958021190Catalog number
07958021190
Lot number
E09933
Product problems
- Packaging Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IN THE PACKET- THE TWO SWABS BOTH HAVE A "BLACK LINE." THIS IS CONFUSING TO STAFF, AND STAFF PLACES BOTH SWABS IN THE PCR MEDIA THAT RESULTS IN THE TEST BEING COMPROMISED AND UNABLE TO BE PROCESSED. ALSO, THERE ARE NO CLEAR DIRECTIONS ON PACKAGING TO HELP MITIGATE THIS ISSUE.