BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK
Received Nov 6, 2023 · Event occurred Oct 11, 2023
Report 1119779-2023-01205 · MDR key 18072769
Device
Generic name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
441126
Lot number
UNKNOWN
Product problems
- False Negative Result
- False Negative Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
3 OF 3: IT WAS REPORTED THAT WHILE CUSTOMER WAS PERFORMING CROSS-PLATFORM TESTING WITH XTR AND MAX USING BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK, PATIENT SAMPLE WAS DISCREPANT ON XTR ONLY. THE RESULTS HAVE NOT BEEN REPORTED.
Additional Manufacturer Narrative
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SYSTEM INITIATED AN INVESTIGATION INTO DISCREPANT RESULTS ON THE BD VIPER XTR SYSTEM (CATALOG # 441126, BATCH # UNKNOWN). BD INVESTIGATION REQUIRED COMPLAINT TRENDING REVIEW. THERE ARE NO CURRENT TRENDS ASSOCIATED WITH DISCREPANT RESULTS ON THE BD VIPER XTR SYSTEM. BD WAS UNABLE TO PERFORM BATCH HISTORY RECORD REVIEWS AND FUNCTIONAL ANALYSIS DUE TO THE LACK IN BATCH INFORMATION PROVIDED. BD WAS UNABLE TO CONFIRM THE CUSTOMERS REPORT.
Description of Event or Problem
3 OF 3: IT WAS REPORTED THAT WHILE CUSTOMER WAS PERFORMING CROSS-PLATFORM TESTING WITH XTR AND MAX USING BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK, PATIENT SAMPLE WAS DISCREPANT ON XTR ONLY. THE RESULTS HAVE NOT BEEN REPORTED.