VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Dec 28, 2015
Report 1950204-2015-00131 · MDR key 5330489
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
AS A RESULT OF JOURNAL PUBLICATION REVIEW BY BIOMÉRIEUX MEDICAL AFFAIRS (UNITED STATES), MISIDENTIFICATION OF ACINETOBACTER URSINGII WAS INDICATED IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION (ID) TEST KIT. THE ORGANISM WAS MISIDENTIFIED AS ACINETOBACTER LWOFFII. THERE IS NO STATEMENT BY THE AUTHOR(S) OF THE JOURNAL ARTICLE THAT ANY DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AS THE CLAIM IS THE GENERAL SUBJECT OF A JOURNAL ARTICLE, THERE IS/ARE NO CULTURE SUBMITTAL(S) AVAILABLE FOR BIOMÉRIEUX INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
BIOMÉRIEUX INVESTIGATION WAS INITIATED. IN THE JOURNAL ARTICLE "A RETROSPECTIVE STUDY OF THE INCIDENCE, CLINICAL CHARACTERISTICS, IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY OF BACTEREMIC ISOLATES OF ACINETOBACTER URSINGII (CHIU ET AL., BMX INFECTIOUS DISEASES 2015, 15:400), THE AUTHORS REPORTED TESTING 19 STRAINS OF ACINETOBACTER URSINGII AND THE VITEK 2 GN ID CARD MIS-IDENTIFIED 10 AS ACINETOBACTER LWOFFII. BIOMÉRIEUX WAS UNABLE TO CONTACT THE AUTHORS OF THE ARTICLE (THEY WERE NOT RESPONSIVE TO ANY INQUIRIES) AND THEREFORE THE ORGANISM STRAINS ARE NOT AVAILABLE FOR TESTING. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE MIS-IDENTIFICATION WITHOUT STRAINS, LAB REPORTS AND/OR RAW DATA. THE ARTICLE DID NOT GIVE ANY SPECIFIC INFORMATION ABOUT THE TEST RESULTS FROM THE VITEK 2 GN ID CARD OR THE LOT NUMBER(S) TESTED. WITHOUT THE LOT NUMBER(S), ASSOCIATED MANUFACTURING BATCH RECORDS CANNOT BE REVIEWED. NO FURTHER INVESTIGATION IS POSSIBLE.