VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Sep 3, 2015
Report 1950204-2015-00023 · MDR key 5054493
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ORGANISM WAS SUBCULTURED, AND TESTING INCLUDED TWO (2) CARDS FROM THE CUSTOMER CARD LOT AND ONE (1) CARD FROM TWO (2) RANDOM LOTS. API 20NE WAS ALSO PERFORMED. FOR ALL CARDS TESTED, A LOW DISCRIMINATION CALL OF ACINETOBACTER LWOFFII / MORAXELLA GROUP WAS OBTAINED. SINCE ACINETOBACTER LWOFFII IS PRESENTED AS A POSSIBLE ORGANISM, THE RESULTS ARE ACCEPTABLE FOR VITEK® 2 TESTING. FOR THE API 20NE, A GOOD IDENTIFICATION (B)(4) OF ACINETOBACTER LWOFFII WAS OBTAINED. THE VITEK® 2 GN ID CARDS ARE PERFORMING WITHIN PERFORMANCE SPECIFICATIONS. THE CUSTOMER RESULT OF MORAXELLA WAS NOT DUPLICATED.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
CUSTOMER REPORTED A MISIDENTIFICATION FOR ACINETOBACTER LWOFFI ((B)(6)). TESTING VIA THE VITEK® 2 GN ID TEST KIT ((B)(4)) PROVIDED A RESULT OF MORAXELLA GROUP . THE CUSTOMER PERFORMED TESTING OF THE CAP SURVEY STRAIN USING API RAPID NH AND RECEIVED AN IDENTIFICATION OF MORAXELLA CATTARHALIS. THE CUSTOMER REPORTED THE RESULT TO CAP AND RECEIVED NOTICE OF THE CORRECT IDENTIFICATION OF ACINETOBACTER LWOFFI. THE CUSTOMER PERFORMED SUB-CULTURE OF THE STRAIN THREE TIMES AND RETESTED USING VITEK® 2 GN ID AND MICROSCAN. RESULT OF MORAXELLA GROUP WAS AGAIN OBTAINED WITH THE VITEK® 2; AN IDENTIFICATION OF ACINETOBACTER LWOFFII WAS REPORTED VIA MICROSCAN. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMÉRIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. SUBMITTAL OF THE CAP SURVEY ORGANISM WAS REQUESTED FROM THE CUSTOMER. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.