VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 22, 2015
Report 1950204-2015-00042 · MDR key 5095569
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN THE UNITED STATES REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT (REF 21341) MISIDENTIFIED AN ESCHERICHIA COLI (E. COLI) ORGANISM AS SHIGELLA. THEY REPEATED TESTING WITH THE VITEK 2 GN ID CARD AND OBTAINED THE SAME RESULT (SHIGELLA). THEY PERFORMED A CONFIRMATION TEST VIA LATEX TEST; THE TEST CONFIRMED THE ORGANISM AS SHIGELLA. THE CUSTOMER ALSO SENT THE ISOLATE TO A REFERENCE LAB WHERE IT WAS IDENTIFIED AS E. COLI VIA MOLECULAR TESTING. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANT ORGANISM IDENTIFICATION IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION TEST KIT (CARD). ESCHERICHIA COLI (E COLI) WAS MISIDENTIFIED AS SHIGELLA SP. PATIENT ISOLATE AND RAW DATA WERE NOT SUBMITTED BY THE CUSTOMER. REVIEW OF THREE LAB REPORTS INDICATED THE REACTIONS FOR THE ISOLATE SHOWED LESS REACTIVITY THAN A TYPICAL E. COLI. WITHOUT THE ISOLATE OR RAW DATA, IT IS NOT POSSIBLE TO FURTHER INVESTIGATE THE CUSTOMER REPORT. THE LAB REPORTS REPORTING AN IDENTIFICATION OF SHIGELLA GROUP ALSO ISSUED THE MESSAGE "CONFIRM BY SEROLOGICAL TESTS". AN IDENTIFICATION OF SHIGELLA SHOULD ALWAYS BE CONFIRMED BY ANOTHER METHOD, SUCH AS SEROLOGY. THE IMPLICATED VITEK® 2 GN ID LOTS (241345040 AND 241339040) PASSED ON INITIAL QC PERFORMANCE TESTING WITH NO ISSUES OBSERVED.