BD MAX¿ ENTERIC BACTERIAL PANEL
Received Dec 30, 2022 · Event occurred Dec 21, 2022
Report 3007420875-2022-00085 · MDR key 16078219
Device
Generic name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Model number
442963Catalog number
442963
Lot number
UNKNOWN
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL SEVERAL FALSE POSITIVES HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX EBP - 442963_UNKNOWN - FP. JAGGED CURVES.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3007420875-2022-00085 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
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.
Description of Event or Problem
IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL SEVERAL FALSE POSITIVES HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX EBP - 442963_UNKNOWN - FP. JAGGED CURVES.