BD MAX¿ ENTERIC BACTERIAL PANEL
Received Aug 16, 2023 · Event occurred Jun 14, 2023
Report 3007420875-2023-00080 · MDR key 17561328
Device
Generic name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
442963
Lot number
3088948
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
REPORT 1 OF 4. IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL PATIENT RESULT WAS POSITIVE FOR VIBRIO ON (B)(6) AND ON REPEAT WAS NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THAT ONE PATIENT RESULT WAS POSITIVE FOR VIBRIO ON (B)(6) AND REPEATED IN DUPLICATE ON (B)(6) AND WERE NEGATIVE. ACCESSION #(B)(6), RUN#1206/1209, POSITION A9/A3 & A4, ENTERIC LOT# 3088948, EXTENDED LOT# 2355384, INITIAL RESULT VIBRIO + FINAL RESULT REPORTED VIBRIO NEG ACCESSION #(B)(6), RUN#1324/1326, POSITION A9/A1 & A2, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT VIBRO + AND YERSINIA + FINAL RESULT REPORTED VIBRIO NEG AND YERSINIA NEG ACCESSION #(B)(6), RUN#1344/1346, POSITION A7/B5 & B6, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT CAMPY + AND YERSINIA + FINAL RESULT REPORTED CAMPY + AND YERSINIA NEG.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. IT WAS DETERMINED BY MANAGEMENT THAT THIS IS NOT A PRODUCT COMPLAINT, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
REPORT 1 OF 4 IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL PATIENT RESULT WAS POSITIVE FOR VIBRIO ON JUNE 14 AND ON REPEAT WAS NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THAT ONE PATIENT RESULT WAS POSITIVE FOR VIBRIO ON JUNE 14 AND REPEATED IN DUPLICATE ON JUNE 15 AND WERE NEGATIVE. ACCESSION #2316403783, RUN#1206/1209, POSITION A9/A3 & A4, ENTERIC LOT# 3088948, EXTENDED LOT# 2355384, INITIAL RESULT VIBRIO + FINAL RESULT REPORTED VIBRIO NEG ACCESSION #2321403879, RUN#1324/1326, POSITION A9/A1 & A2, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT VIBRO + AND YERSINIA + FINAL RESULT REPORTED VIBRIO NEG AND YERSINIA NEG ACCESSION #2322001055, RUN#1344/1346, POSITION A7/B5 & B6, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT CAMPY + AND YERSINIA + FINAL RESULT REPORTED CAMPY + AND YERSINIA NEG
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.