VITEK 2 NH TEST KIT
Received Aug 10, 2015 · Event occurred Aug 3, 2015
Report 1950204-2015-00016 · MDR key 4988566
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED THE VITEK NEISSERIA HAEMOPHILUS (NH) ID TEST KIT ((B)(4), LOT NUMBER 245354220) MISIDENTIFIED A (B)(6) (99% PROBABILITY). THE CUSTOMER RETESTED THE ORGANISM WITH THE VITEK 2 NH TEST KIT (LOT NUMBER 245359410) AND RECEIVED A LOW DISCRIMINATION RESULT OF (B)(6). THE CUSTOMER TESTED THE STRAIN VIA PCR METHOD, WITH A RESULT OF (B)(6). THE VITEK RESULTS WERE NOT REPORTED TO THE CLINICIAN. THE PCR RESULT OF (B)(6) WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMEDIEUX THAT THE ORGANISM MISIDENTIFICATION LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. INTERNAL BIOMEDIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
INTERNAL INVESTIGATION WAS CONDUCTED. HOWEVER, RAW DATA AND THE ISOLATE WERE NOT SUBMITTED FOR EVALUATION. A REVIEW OF THE CUSTOMER'S LAB REPORTS WERE INSUFFICIENT TO PROVIDE ROOT CAUSE OF THE MISIDENTIFICATION. REVIEW OF HISTORICAL COMPLAINT RECORDS INDICATES NO ADDITIONAL COMPLAINTS FOR LOT 245354220. FOR LOT 245359410, ONE COMPLAINT WAS RECORDED DUE TO A QC DEVIATION WITH S. EPIDERMIDIS. IN ADDITION, REVIEW OF THE QC BATCH RECORDS REVEAL THE CARD LOTS PASSED QC ON INITIAL TESTING. SINCE ONLY THE LAB REPORT WAS SUBMITTED, ITS NOT POSSIBLE TO FURTHER REVIEW THIS OCCURRENCE.