API ® 20 NE
Received Nov 17, 2015
Report 3002769706-2015-00147 · MDR key 5229483
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION WAS PERFORMED TO DETERMINE THE ROOT CAUSE OF A MIS-IDENTIFICATION OF A CAP SURVEY SAMPLE (PROFICIENCY SAMPLE) OBTAINED WHEN USING THE API® 20 NE KIT. THE CUSTOMER IDENTIFIED A VIBRIO VULNIFICUS SAMPLE AS OCHROBACTER ANTHROPI. THE CUSTOMER RETURNED THE CAP SURVEY SAMPLE TO BIOMERIEUX FOR TESTING. TESTING COULD NOT BE PERFORMED ON THE LOT THE CUSTOMER UTILIZED AS IT WAS PAST EXPIRY. THE CUSTOMER SAMPLE WAS TESTED IN DUPLICATE ON RESERVE SAMPLES FROM 2 DIFFERENT LOTS OF API® 20 NE. ADDITIONALLY, THE SAMPLE WAS TESTED ON THE VITEK® MS AS A CONFIRMATORY METHOD. ALL TESTING PERFORMED AT BIOMERIEUX RETURNED THE PROPER IDENTIFICATION OF VIBRIO VULNIFICUS. THEREFORE, THE CUSTOMER'S RESULT COULD NOT BE CONFIRMED. BASED ON THIS TESTING PERFORMED, NO DEFECT WAS DETECTED; THE PRODUCT IS PERFORMING AS INTENDED.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER CONTACTED BIOMERIEUX TO REPORT A MISIDENTIFICATION ASSOCIATED WITH API 20 NE. THE CAP SURVEY ISOLATE WAS VIBRIO VULCANIS, HOWEVER API 20 NE IDENTIFIED THE ISOLATE AS OCHROBACTER ANTHROPIC. THE CUSTOMER PERFORMED ADDITIONAL TESTING WITH BLOOD, CHOCOLATE AND ANAEROBIC PLATES AND A PHOENIX SYSTEM WITH THE SAME RESULT OF OCHROBACTER ANTHROPIC. THE CUSTOMER NO LONGER HAS THE ORGANISM OR SWABS FOR FURTHER ANALYSIS. THERE WAS NO REPORTED PATIENT HARM OR DELAYED RESULTS ASSOCIATED.