BD CTGCTV2
Received Dec 11, 2024 · Event occurred Oct 23, 2024
Report 3007420875-2024-00180 · MDR key 20902537
Device
Generic name
Multiple-type Sexually Transmitted Pathogen Nucleic Acid Ivd, Kit, Nucleic Acid
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
443979
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY, QEP . A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 ON BD MAX INSTRUMENT, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING THE REAGENTS AND INSTRUMENT, IT WAS VISIBLE THAT A "BLOODY SLIME STRING" FROM A SAMPLE WAS DRAGGED OVER THE PROCESS AREA AND CONTAMINATED THE SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE PREVIOUS MFR REPORT # 3007420875-2024-00180 WAS SUBMITTED AGAINST WRONG PRODUCT. THIS REPORT IS TO BE REPLACE BY MFR REPORT # 1119779-2025-00272.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 ON BD MAX INSTRUMENT, 8 SAMPLES WERE FALSE POSITIVE FOR BOTH CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE. AFTER INSPECTING THE REAGENTS AND INSTRUMENT, IT WAS VISIBLE THAT A "BLOODY SLIME STRING" FROM A SAMPLE WAS DRAGGED OVER THE PROCESS AREA AND CONTAMINATED THE SAMPLES. CLEANING AND ENVIRONMENTAL TESTING WERE PERFORMED. SAMPLES WERE RERUN AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.