VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Received Jan 14, 2016 · Event occurred Nov 27, 2015
Report 1950204-2016-00007 · MDR key 5366270
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
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING INCLUDED THE CUSTOMER LOT AND TWO (2) RANDOM LOTS OF VITEK® 2 GN ID CARDS. API® 20 E WAS ALSO PERFORMED. ON THE CUSTOMER LOT AND ONE RANDOM LOT OF GN ID CARDS, AN ID OF KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE WAS OBTAINED. ON THE SECOND RANDOM LOT OF GN ID CARDS, AN ID OF KLEBSIELLA OXYTOCA WAS OBTAINED. API® 20 E GAVE AN ID OF KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE. THEREFORE, THE FINAL IDENTIFICATION IS K. PNEUMONIAE SSP PNEUMONIAE. A COMPARISON OF REACTION RESULTS FOR THE CARD GIVING THE KLEBSIELLA OXYTOCA IDENTIFICATION AGAINST THE EXPECTED REACTION RESULTS FOR KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE REVEALED ONE ATYPICAL POSITIVE REACTION (5KG) THAT CONTRIBUTED TO THE MISIDENTIFICATION. IT SHOULD ALSO BE NOTED THAT THE ANALYSIS TIME FOR THE CARD GIVING A KLEBSIELLA OXYTOCA IDENTIFICATION (3.75 HOURS) WAS MUCH SHORTER THAN THAT FOR CARDS GIVING THE CORRECT IDENTIFICATION (8.25-8.50 HOURS). THE INVESTIGATION CONCLUDED THAT THE PATIENT ISOLATE IS AN ATYPICAL STRAIN HAVING IRREGULAR OR INCONSISTENT GROWTH CHARACTERISTICS. THE VITEK® 2 GN ID CARDS ARE PERFORMING AS EXPECTED.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED THE VITEK 2 GRAM-NEGATIVE (GN) ID TEST KIT PROVIDED INCONSISTENT IDENTIFICATION RESULTS FOR A SINGLE PATIENT ISOLATE. THE INITIAL GN ID TEST OBTAINED A RESULT OF KLEBSIELLA OXYTOCA. THE CUSTOMER ALWAYS PERFORMS AN INDOLE TEST FOR THIS ORGANISM; THE RESULT WAS NEGATIVE, WHICH THE CUSTOMER CONSIDERED ODD FOR THIS ORGANISM ID. THE CUSTOMER RETESTED THE ISOLATE VIA GN ID CARD; THE REPEAT TEST PROVIDED KLEBSIELLA PNEUMONIAE. BOTH GN ID CARDS WERE INOCULATED FROM THE SAME BLOOD CULTURE BOTTLE. KLEBSIELLA OXYTOCA WAS REPORTED TO THE PHYSICIAN DESPITE THE NEGATIVE INDOLE RESULT; THIS IS BECAUSE OF THE EXCELLENT IDENTIFICATION (98%) REPORTED BY THE VITEK 2 GN ID CARD. THE CUSTOMER PERFORMED NO TESTING OF THE ISOLATE VIA ALTERNATE METHOD. THEREFORE; THERE IS NO CONFIRMATION OF EITHER RESULT. BIOMERIEUX HAS REQUESTED SUBMITTAL OF PATIENT ISOLATE FOR INTERNAL TESTING. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.