API® CORYNE
Received Oct 20, 2015
Report 3002769706-2015-00122 · MDR key 5160212
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING INCLUDED 16S SEQUENCING AND API® CORYNE STRIP. 16S SEQUENCING CONFIRMED THE IDENTIFICATION OF ACTINOBACULUM SHAALII. API® CORYNE IDENTIFIED THE ORGANISM AS GARDNERELLA VAGINALIS OR ACTINOMYCES TURICENSIS. THE SPECIES ACTINOBACULUM SCHAALII IS NOT IN THE KNOWLEDGE BASE OF API® CORYNE; THEREFORE IDENTIFICATION TO THE EXPECTED RESULT WAS NOT POSSIBLE. AS THE API® CORYNE SYSTEM IS INTENDED UNIQUELY FOR THE IDENTIFICATION OF CORYNEFORM BACTERIA (GENUS CORYNEBACTERIUM AND RELATED GENERA) INCLUDED IN THE DATABASE, IT CANNOT BE USED TO IDENTIFY ANY OTHER MICROORGANISMS OR TO EXCLUDE THEIR PRESENCE. THE DATABASE OF THIS PRODUCT IS LIMITED TO THOSE CORYNEFORM BACTERIA MOST FREQUENTLY ISOLATED FROM CLINICAL SPECIMENS. THE API® CORYNE PRODUCT IS PERFORMING WITHIN SPECIFICATIONS.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
ON (B)(6) 2015 CUSTOMER CALLED TO REPORT A MIS-IDENTIFICATION WHEN USING API CORYNE, REF. 20900, LOT 1004103300. SPECIMEN RESULTS GARNERELLA VAGINALIS BACTERIA WAS GRAM POSITIVE AFTER 48 HOURS INCUBATION, CORRECT RESULTS SHOULD HAVE BEEN ACTINOBACULUM SHAALII. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM ADDITIONAL TESTING. NO PATIENT HARM HAS BEEN REPORTED.