BD PHOENIX¿ PMIC/ID-106
Report
- Report Number
- 1119779-2024-00975
- Event Type
- Malfunction
- Date Received
- December 10, 2024
- Date of Event
- November 20, 2024
- Report Date
- March 24, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904486069
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020322, K021954, K022172, K023273, K023301, K024152, K030677, K031306, K031679, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050555, K051689, K053241, K060214, K060217, K060218, K060218, K060493, K082538, K082852, K082913, AND K131331. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL- YES. D10. RETURNED TO MANUFACTURER ON: 11-DEC-2024. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STREPTOCOCCUS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 4191582. THE CUSTOMER PROVIDED PANELS, AN ISOLATE AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF STREPTOCOCCUS AGALACTIAE WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATE WAS VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS S. AUREUS. TO INVESTIGATE, CUSTOMER RETURNED PANELS, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT A DIFFERENT BATCH NUMBER WERE TESTED USING CUSTOMER RETURNED ISOLATE S. AUREUS ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS TESTED RETURNED THE CORRECT IDENTIFICATION. THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID- (B)(6) A PATIENT ISOLATE (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS - MRSA) WAS MISIDENTIFIED AS GROUP B STREP. REPEAT TESTING WAS PERFORMED CAUSING THE ISOLATE TO BE MISIDENTIFIED TWICE. THE USER NOTED THAT THE ISOLATE DID NOT APPEAR TO BE A STREP THEREFORE, THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY GIVING THE CONFIRMED RESULT OF MRSA. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-106 A PATIENT ISOLATE (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS - MRSA) WAS MISIDENTIFIED AS GROUP B STREP. REPEAT TESTING WAS PERFORMED CAUSING THE ISOLATE TO BE MISIDENTIFIED TWICE. THE USER NOTED THAT THE ISOLATE DID NOT APPEAR TO BE A STREP THEREFORE, THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY GIVING THE CONFIRMED RESULT OF MRSA. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2577029 | BD PHOENIX¿ PMIC/ID-106 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4191582 | 30382904486069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |