BD PHOENIX¿ PID
Report
- Report Number
- 1119779-2023-01104
- Event Type
- Malfunction
- Date Received
- October 12, 2023
- Date of Event
- September 12, 2023
- Report Date
- January 31, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LQL
- UDI-DI
- 30382904480081
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D.4. MEDICAL DEVICE LOT #: 3102110. D.4. MEDICAL DEVICE EXPIRATION DATE: 01-APR-2024. H.4. MEDICAL DEVICE MANUFACTURING DATE: 12-APR-2023. H6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS AGALACTIAE WHEN USING PHOENIX PANEL PID (CATALOG NUMBER 448008) BATCH NUMBER 3102110. THE CUSTOMER DID NOT RETURN ISOLATES BY THE TIME OF INVESTIGATION OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW A PATIENT ISOLATE IDENTIFIED AS S. AGALACTIAE ON THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS FROM COMPLAINT BATCH 3102110 WERE TESTED USING QC ISOLATE S. AUREUS A29213 ON A PHOENIX M50 AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE S. AUREUS A29213 ON A PHOENIX M50 AND EVALUATED FOR IDENTIFICATION RESULTS. ALL FIVE PANELS IDENTIFIED THE ISOLATE AS S. AUREUS. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3102110. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. H3 OTHER TEXT : SEE H10.
BATCH NUMBER [31021110] WAS NOT FOUND FOR MATERIAL NUMBER [448008]. MANUFACTURING LOCATION WAS NOT FOUND FOR LOT #31021110. THEREFORE, BD CORPORATE HEADQUARTERS IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. E.1 INITIAL REPORTER ADDR 1: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STRAIN HAS BEEN MISIDENTIFIED AS A STREPTOCOCCUS AGALACTIAE WHEN IN FACT IN WAS AN STAPHYLOCOCCUS AUREUS (CONFIRMED BY PHOENIX AND MASS CYTOMETRY).
IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PID THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STRAIN HAS BEEN MISIDENTIFIED AS A STREPTOCOCCUS AGALACTIAE WHEN IN FACT IN WAS AN STAPHYLOCOCCUS AUREUS (CONFIRMED BY PHOENIX AND MASS CYTOMETRY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585474 | BD PHOENIX¿ PID | GRAM POSITIVE IDENTIFICATION PANEL | LQL | BECTON DICKINSON & CO. (SPARKS) | 3102110 | 30382904480081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |