BD KIESTRA IDENTIFA
Received Oct 8, 2025 · Event occurred Sep 15, 2025
Report 3010141591-2025-00011 · MDR key 23247882
Device
Generic name
Microbial Specimen Inoculation/streaking/colony-picking Instrument Ivd
Manufacturer
Bd Kiestra Lab AutomationCatalog number
444063
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. D.2. MEDICAL DEVICE TYPE: QBN / QQV. D.4. MEDICAL DEVICE EXPIRATION DATE: N/A. G.5. PMA/510(K)#: K191964 / K222563.
Description of Event or Problem
IT HAS BEEN REPORTED THAT THE BD KIESTRA IDENTIFA HAS BEEN FOUND EXPERIENCING MISASSOCIATION OF SAMPLE DATA. NO PATIENT IMPACT WAS REPORTED.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING THE BD KIESTRA IDENTIFA. ACCORDING TO THE INFORMATION PROVIDED, THE CUSTOMER REPORTED THAT AN IDENTIFA CUVETTE LOADED ON THE SYSTEM CONTAINED SAMPLE DATA FROM APPROXIMATELY THREE MONTHS EARLIER. NO OTHER ISSUES WERE REPORTED. DURING THE INVESTIGATION, A TECHNICAL SOLUTIONS MANAGER (TSM) REVIEWED THE CUVETTE DATA IN SYNAPSYS AND CONFIRMED THAT THE SAMPLES ORIGINATED FROM MAY. SYNAPSYS AUDIT LOGS SHOWED CORRECT BEHAVIOR, AND IDENTIFA LOGS DID NOT SHOW ANY RECENT SCANS OF THIS CUVETTE. NO SYSTEM-RELATED MALFUNCTION WAS DETECTED. THE INVESTIGATION INDICATED THE ISSUE RESULTED FROM CUSTOMER WORKFLOW PRACTICES, AS CUVETTES WITH BARCODE SCANNING ISSUES HAD BEEN KEPT ASIDE, AND THE AFFECTED CUVETTE HAD BEEN MISPLACED INTO THAT GROUP. FOLLOWING THIS ACTION, NO FURTHER ISSUES WERE ENCOUNTERED. BASED ON THE INVESTIGATION, THIS CASE HAS BEEN ASSESSED AS UNCONFIRMED FOR A BD QUALITY ISSUE. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. THE ISSUE IN THIS COMPLAINT DOES NOT REQUIRE THE INITIATION OF A CORRECTIVE AND PREVENTATIVE ACTION (CAPA). A DESIGN HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS ASSOCIATED WITH THIS ISSUE.
Description of Event or Problem
IT HAS BEEN REPORTED THAT THE BD KIESTRA IDENTIFA HAS BEEN FOUND EXPERIENCING MISASSOCIATION OF SAMPLE DATA. NO PATIENT IMPACT WAS REPORTED.