VITEK® REVEAL¿ SENSOR PANEL
Received Jun 24, 2025
Report 1950204-2025-00005 · MDR key 22313490
Device
Product problems
- Unable to Obtain Readings
- Appropriate Device Problem Term/Code Not Available
- Unable to Obtain Readings
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- No Clinical Signs, Symptoms or Conditions
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF DISCORDANT RESULTS FOR ANTIBIOTICS : CEFTAZIDIME -POTENTIAL FALSE SUSCEPTIBLE RESULTS IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. 101724GWA). CUSTOMER REPORTED THAT WHEN COMPARING THE RESULTS OBTAINED WITH VITEK REVEAL AND MICRODILUTION THE CUSTOMER REPORTED DISCORDANT RESULTS. RESULTS ARE SUMMARIZED BELOW: (B)(4): THE LOT NUMBERS ARE 101724GWA FOR THE SENSOR AND (B)(6) 2025. ANTIBIOTIC CEFTAZIDIME REPORTED MIC 0.5 S WHILE IT WAS RESISTANT WITH DIFFUSION DISK. UNDER THE SUSPICION THAT THE VITEK REVEAL RESULTS WERE NOT CORRECT, THEY WERE NOT REPORTED AND THEREFORE DID NOT HAVE ANY EFFECT ON THE TREATMENT OF THE PATIENT. BIOMÉRIEUX LOCAL CUSTOMER SERVICE INDICATED THAT AFTER TAKING A LOOK TO THE TROUBLESHOOTING FILES, SOME LEAK GRAPHS SEEM TO LOOK ABNORMAL, WHICH COULD INDICATE LEAKAGE BETWEEN WELLS. THIS HAS BEEN COMMUNICATED TO THE CUSTOMER. AT THE TIME OF THE GLOBAL ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.
Additional Manufacturer Narrative
THE CUSTOMER COMPLAINT ASSOCIATED WITH THIS MDR WAS INITIALLY DOCUMENTED AGAINST THE VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002). THIS PRODUCT IS REGISTERED WITH FDA UNDER 510(K) K230675. DURING INVESTIGATION OF THE REPORTED EVENT, IT WAS SUBSEQUENTLY DETERMINED THE COMPLAINT WAS IN FACT RELATED TO VITEK® REVEAL¿ GN01-AST (20 TESTS) - 900-00008. THIS PRODUCT IS AN EXPORT-ONLY PRODUCT THAT IS NOT REGISTERED WITH FDA, AND IS NOT DISTRIBUTED IN THE UNITED STATES. THEREFORE, THE EVENT IS NOT REPORTABLE TO FDA. THIS SUPPLEMENT REPORT SERVES TO CLOSE THIS RECORD.