API® CORYNE 12 STRIPS
Received Oct 15, 2015
Report 3002769706-2015-00117 · MDR key 5152852
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING INCLUDED 16S SEQUENCING AND API® CORYNE STRIP. THE 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 A CUSTOMER CALLED TO REPORT A MIS-IDENTIFICATION WHEN USING PRODUCT API® CORYNE STRIPS, REF. (B)(4), LOT 1003573550. CUSTOMER USED API® STREPTO (AEROCOCCUS UREALITICUM) WHICH PROVIDED INCORRECT RESULTS, EXPECTED RESULTS SHOULD HAVE BEEN ACTINOBACULUM SCHAALII. CUSTOMER USED TWO DIFFERENT API STRIPS TO TEST THIS CNQ (API® CORYNE AND API® STREPTO).