API® 20 NE 25STRIPS+25MEDIA
Received Mar 21, 2016
Report 3002769706-2016-00057 · MDR key 5513986
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
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED DISCREPANT RESULTS OF ENTEROCOCCUS FAECIUM INSTEAD OF THE EXPECTED E. GALLINARUM WHILE USING; API 20 NE 25STRIPS+25MEDIA. THE CUSTOMER REPEATED THE STRIPS TWICE AND ON BOTH OCCASIONS; THE SAME RESULT WAS OBTAINED. THERE IS NO EVIDENCE/INDICATION OF THE FOLLOWING: INJURY OR DEATH TO A PATIENT; EVIDENCE THAT A PATIENT UNDERWENT ANY UNNECESSARY MEDICAL PROCEDURE DUE TO THE REPORTED EVENT; PHYSICIAN ALLEGING THE REPORTED EVENT CAUSED HIM/HER TO PROVIDE INCORRECT TREATMENT.
Additional Manufacturer Narrative
AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. API® 20 STREP, RAPID ID 32 STREP, BP CARD (WITH VITEK® 2 V6.01 AND V7.01) AND VITEK® MS ON STRAIN LOT 2-411 WERE TESTED. ON API WEB BASE (V8.0), GOOD IDENTIFICATION TO THE GENUS AEROCOCCUS VIRIDANS AFTER 4H WAS OBTAINED AND A LOW DISCRIMINATION TO LACTOCOCCUS LACTIS SPP LACTIS, AEROCOCCUS VIRIDANS OR ENTEROCOCCUS FAECIUM (ID 1.7%) AFTER 24H; NO IDENTIFICATION OBTAINED WITH API® 20 STREP STRIP. THE EXPECTED SPECIES E. GALLINARUM IS NOT INCLUDED IN THE API® 20 STREP KNOWLEDGE BASE. THE PRODUCT IS PERFORMING AS INTENDED WITHIN SPECIFICATION.