VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Aug 11, 2016
Report 1950204-2016-00093 · MDR key 5868700
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- 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 (B)(6) CONTACTED BIOMERIEUX TO REPORT A MISIDENTIFICATION OF ESCHERICHIA COLI (E. COLI) AS ESCHERICHIA COLI 0157 IN ASSOCIATION WITH THE VITEK 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE CUSTOMER PERFORMED LATEX AGGLUTINATION TEST TO CONFIRM 0157; THE TEST WAS NEGATIVE. THE CUSTOMER TESTED VIA CHROMOGENIC E. COLI MEDIA; THE RESULT WAS NEGATIVE. API 20E WAS ALSO PERFORMED AND OBTAINED A RESULT OF ESCHERICHIA COLI; HOWEVER, IT SHOULD BE NOTED THAT ESCHERICHIA COLI 0157 IS NOT IN ANY OF THE API DATABASES. BASED ON THE LATEX AND CHROMOGENIC MEDIA RESULT, THE RESULT OF E. COLI WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
THIS REPORT WAS INITIALLY SUBMITTED DUE TO VITEK® 2 GN ID MISIDENTIFICATION OF ESCHERICHIA COLI AS ESCHERICHIA COLI 0157. THE CUSTOMER SUBMITTED TWO STRAINS (S1 AND S2) FOR EVALUATION. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. INVESTIGATIONAL TESTING INCLUDED: REFERENCE METHOD: PCR O157 WAS PERFORMED AND THE RESULT WAS NEGATIVE (NOT IN FAVOR OF ESCHERICHIA COLI O157). ALTERNATIVE METHODS: VITEK® MS: VERY GOOD IDENTIFICATION TO ESCHERICHIA COLI (99.9%) WITH BOTH STRAINS. ID32E STRIP: S1: VERY GOOD IDENTIFICATION TO ESCHERICHIA COLI (99.9%); S2: VERY GOOD IDENTIFICATION TO ESCHERICHIA COLI (99.9% ). VITEK® 2 GN ID (CUSTOMER LOT + RANDOM LOT): S1: BOTH LOTS (CL AND RL) OBTAINED EXCELLENT IDENTIFICATION TO ESCHERICHIA COLI O157 (99%). S2: BOTH LOTS (CL AND RL) OBTAINED EXCELLENT IDENTIFICATION TO ESCHERICHIA COLI (99%). THE INVESTIGATION DUPLICATED THE CUSTOMER RESULT FOR S1; THIS DUE TO ATYPICAL BIOCHEMICAL PROFILE OBSERVED ON VITEK® 2. THE IDENTIFICATION WAS CONFIRMED TO THE SPECIES ESCHERICHIA COLI VIA VITEK® MS AND ID32E STRIP. THE INVESTIGATION CONCLUDED THIS IS AN ATYPICAL STRAIN FOR THE VITEK® 2 GN KNOWLEDGE BASE.