BD PHOENIX¿ PMIC/ID-107
Report
- Report Number
- 1119779-2022-00504
- Event Type
- Malfunction
- Date Received
- April 4, 2022
- Date of Event
- March 9, 2022
- Report Date
- July 12, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904486076
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE BD PHOENIX BD PHOENIX¿ PMIC/ID-107 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K020322, K021954, K023273, K023301, K024152, K030677, K031306, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, K131331. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6 INVESTIGATION SUMMARY : THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS EPIDERMIDIS AND STAPHYLOCOCCUS EPIDERMIDIS AS STAPHYLOCOCCUS HAEMOLYTICUS WHEN USING PHOENIX PANEL PMIC/ID-107 (448607) BATCH NUMBER 1266643. THE CUSTOMER DID RETURN ISOLATES, BUT DID NOT RETURN PANELS OR LAB REPORTS. TO INVESTIGATE, A TOTAL OF THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES OF STAPHYLOCOCCUS AUREUS AND TWO RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING IN HOUSE ISOLATES OF STAPHYLOCOCCUS EPIDERMIDIS ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ALL PANELS IDENTIFIED CORRECTLY AS STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS EPIDERMIDIS RESPECTIVELY. ADDITIONALLY, ONE CONTROL PANEL WAS TESTED USING CUSTOMER RETURNED ISOLATES OF STAPHYLOCOCCUS AUREUS, THIS PANEL YIELDED SATISFACTORY IDENTIFICATION RESULTS. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED SIX ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH NOT ALL RELATED TO THIS DEFECT. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. BD ENCOURAGES YOU TO CONSIDER THE FOLLOWING PARAMETERS TO OPTIMIZE RESULTS WITHIN YOUR LABORATORY. QC TESTING SHOULD ONLY BE PERFORMED ON 2ND PASS SUBCULTURES AND AVOID USING COLONIES THAT HAVE BEEN SUB-CULTURED MULTIPLE TIMES. ISOLATED COLONIES ARE TO BE USED FOR INOCULATION AND CAREFULLY CHECK PURITY PLATES TO ENSURE THE INOCULUM CONSISTED OF ONE ISOLATE TYPE. OPTIMUM PERFORMANCE COMES FROM USING FRESH 18-24 HOUR, WELL-ISOLATED COLONIES. ENSURE PROPER, SUFFICIENT INOCULUM DENSITY. ALLOW BUBBLES TO DISSIPATE AFTER VORTEXING. PROPERLY CALIBRATE THE BD PHOENIXSPEC¿ NEPHELOMETER WITH IN-DATE MCFARLAND CALIBRATION STANDARDS. USE SWABS WITH MINIMAL FIBER SHED. MAKE THE PROPER INOCULUM DENSITY FOR THE INOCULUM SYSTEM SETTING (I.E., IF PREPARING A 0.25 MCFARLAND INOCULUM, ENSURE THAT THE SYSTEM IS SET TO 0.5 INOCULUM MODE). VOLUME OF ID BROTH SHOULD BE VISUALLY ASSESSED FOR ANY OBVIOUS LOW FILLS. ENSURE PROPER INCUBATION TEMPERATURE AND ENVIRONMENT. USE THE CORRECT MEDIA TYPE AS LISTED AS ACCEPTABLE FOR USE IN THE USER¿S MANUAL (NOTE - IT IS HELPFUL TO DISCLOSE THE MEDIA TYPE AND VENDOR WHEN PROVIDING THE DETAILS OF THE COMPLAINT). HANDLE PANELS BY ONLY TOUCHING THE SIDES; TOUCHING THE FRONT OR BACK OF THE PANELS MAY CAUSE INTERFERENCE IN THE READINGS AND LEAD TO ERRORS. FOLLOW USER¿S MANUAL INSTRUCTIONS FOR TIME LIMITS ON POURING INOCULATED ID BROTH INTO THE PANEL AND PLACING THE PANEL INTO THE INSTRUMENT; EXTENDED PERIODS OF TIME OUTSIDE OF THE STATED LIMITATIONS MAY YIELD ERRORS.
REPORT 2 OF 3 IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX¿ PMIC/ID-107, ERRONEOUS RESULTS WERE OBTAINED. S. AUREUS WAS INCORRECTLY IDENTIFIED AS S. EPIDERMIDIS. RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS MIS-IDENTIFICATION. ROBERTA ALALADE : (B)(6) 2022 14:57:42 (GMT) WHAT IS THE SOFTWARE VERSION OF YOUR PHOENIX? V6.91A. WHAT IS THE SOFTWARE VERSION AND PUD OF YOUR EPICENTER? V7.45A SR1. HAVE ANY OTHER BENCHTOP OR BIOCHEMICAL/MOLECULAR TESTS BEEN PERFORMED AND WHAT WERE THE RESULTS? CATALASE POSITIVE, COAGULASE POSITIVE FOR THE STAPHYLOCOCCUS AUREUS MIS-ID. THE S. EPIDERMIDIS WAS CATALASE POSITIVE, COAGULASE NEGATIVE. WERE ANY PATIENT RESULTS REPORTED OUT? YES WERE ANY PATIENT TREATMENT/MANAGEMENT CARE CHANGED DUE TO THIS MISID? NO PLEASE PROVIDE SPECIMEN LAB REPORTS FOR REFERENCE (REMOVING/COVERING ANY PHI IF PRESENT)? DO YOU HAVE THE ISOLATE AVAILABLE FOR RETURNS? THE STAPHYLOCOCCUS AUREUS ISOLATE IS AVAILABLE FOR RETURN, BUT THE S EPIDERMIDIS IS NOT AVAILABLE. HOW MANY ISOLATES WILL YOU BE SENDING FOR INVESTIGATION AND WHAT ARE THE IDS? ONE ISOLATE. ACCESSION NUMBER 90735763 ARE YOU ABLE TO RETURN THE PANEL ISOLATE FOR INVESTIGATION? NO PANEL SEQUENCE NUMBERS AFFECTED: PLEASE SPECIFY ALL PANEL SEQUENCE NUMBERS AFFECTED? THE PANEL SEQUENCE NUMBER THAT MIS-ID¿D THE STAPH. AUREUS AS EPIDERMIDIS WAS 426072039942 AND THE PANEL SEQUENCE NUMBERS THAT MIS-ID¿D STAPH EPIDERMIDIS AS S. HAEMOLYTICUS WERE 426072040021 AND 426072039998. ROBERTA ALALADE : 2022-03-10 14:57:10 (GMT). HOW MANY BOXES OF THE PMIC/ID OF THE SAME LOT WERE RECEIVED IN TOTAL? UNSURE WERE THESE ORDERED FROM A DISTRIBUTOR OR DIRECTLY FROM BD? DISTRIBUTER: FISCHER ARE MULTIPLE PANEL LOTS AFFECTED? UNSURE. PLEASE PROVIDE THE FOLLOWING LOT NUMBERS AND STORAGE CONDITIONS. PANEL: 126643 AMBIENT 20 C. ID BROTH: 1335976 AMBIENT 20 C. AST BROTH/AST-S BROTH: 1196577 AMBIENT PROTECTED FROM LIGHT. 4.5ML AST BROTH (IF APPLICABLE). AST INDICATOR/AST-S INDICATOR: 1215417. WHAT IS THE OPEN DATE ON YOUR INDICATOR? CHANGED EVERY 5 DAYS FOR AP. HOW OLD WERE THE ORGANISMS UPON PREPARATION OF INOCULUM? 18-24 HOURS. PLEASE PROVIDE THE MANUFACTURER AND TYPE OF MEDIA CULTURES WERE BEING SET UP FROM? REMEL BAP. WAS CULTURE PURITY CONFIRMED? YES. WHAT IS THE SOURCE OF CULTURE(S) FOR THE ORGANISMS YOU HAVE HAD ISSUES WITH? WOUND AND BLOOD. DO YOU USE AN AP FOR SETUP OR DO YOU SET UP PANELS MANUALLY? AP. HAS AP CONTAMINATION BEEN RULED OUT? YES. WHAT IS THE INOCULUM DENSITY USED? 0.5. MANUAL SETUP SPECIFIC: NA. ARE YOUR CALIBRATORS IN DATE? YES. HOW LONG DO BROTHS SIT PRIOR TO PANEL INOCULATION? LESS THAN 30 MIN. HOW LONG AFTER PANEL INOCULATION ARE PANELS LOADED ONTO INSTRUMENT? LESS THAN 30 MIN. DO YOU USE A PHOENIX 100 OR M50? M50. WHAT IS THE SN OF YOUR PHOENIX? PF1408.
REPORT 2 OF 3. IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX¿ PMIC/ID-107, ERRONEOUS RESULTS WERE OBTAINED. S. AUREUS WAS INCORRECTLY IDENTIFIED AS S. EPIDERMIDIS. RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS MIS-IDENTIFICATION. (B)(6): 2022-03-10 14:57:42 (GMT). WHAT IS THE SOFTWARE VERSION OF YOUR PHOENIX? V6.91A. WHAT IS THE SOFTWARE VERSION AND PUD OF YOUR EPICENTER? V7.45A SR1. HAVE ANY OTHER BENCHTOP OR BIOCHEMICAL/MOLECULAR TESTS BEEN PERFORMED AND WHAT WERE THE RESULTS? CATALASE POSITIVE, COAGULASE POSITIVE FOR THE STAPHYLOCOCCUS AUREUS MIS-ID. THE S. EPIDERMIDIS WAS CATALASE POSITIVE, COAGULASE NEGATIVE. WERE ANY PATIENT RESULTS REPORTED OUT? YES. WERE ANY PATIENT TREATMENT/MANAGEMENT CARE CHANGED DUE TO THIS MISID? NO. PLEASE PROVIDE SPECIMEN LAB REPORTS FOR REFERENCE (REMOVING/COVERING ANY PHI IF PRESENT)? DO YOU HAVE THE ISOLATE AVAILABLE FOR RETURNS? THE STAPHYLOCOCCUS AUREUS ISOLATE IS AVAILABLE FOR RETURN, BUT THE S EPIDERMIDIS IS NOT AVAILABLE. HOW MANY ISOLATES WILL YOU BE SENDING FOR INVESTIGATION AND WHAT ARE THE IDS? ONE ISOLATE. ACCESSION NUMBER: (B)(6). ARE YOU ABLE TO RETURN THE PANEL ISOLATE FOR INVESTIGATION? NO. PANEL SEQUENCE NUMBERS AFFECTED: PLEASE SPECIFY ALL PANEL SEQUENCE NUMBERS. AFFECTED? THE PANEL SEQUENCE NUMBER THAT MIS-ID¿D THE STAPH. AUREUS AS EPIDERMIDIS WAS (B)(4) AND THE PANEL SEQUENCE NUMBERS THAT MIS-ID¿D STAPH EPIDERMIDIS AS S. HAEMOLYTICUS WERE (B)(4). (B)(6): 2022-03-10 14:57:10 (GMT). HOW MANY BOXES OF THE PMIC/ID OF THE SAME LOT WERE RECEIVED IN TOTAL? UNSURE WERE THESE ORDERED FROM A DISTRIBUTOR OR DIRECTLY FROM BD? DISTRIBUTER: FISCHER. ARE MULTIPLE PANEL LOTS AFFECTED? UNSURE. PLEASE PROVIDE THE FOLLOWING LOT NUMBERS AND STORAGE CONDITIONS: PANEL: 126643 AMBIENT 20 C. ID BROTH: 1335976 AMBIENT 20 C. AST BROTH/AST-S BROTH: 1196577 AMBIENT PROTECTED FROM LIGHT. 4.5ML AST BROTH (IF APPLICABLE). AST INDICATOR/AST-S INDICATOR: 1215417. WHAT IS THE OPEN DATE ON YOUR INDICATOR? CHANGED EVERY 5 DAYS FOR AP. HOW OLD WERE THE ORGANISMS UPON PREPARATION OF INOCULUM? 18-24 HOURS. PLEASE PROVIDE THE MANUFACTURER AND TYPE OF MEDIA CULTURES WERE BEING SET UP FROM? REMEL BAP. WAS CULTURE PURITY CONFIRMED? YES. WHAT IS THE SOURCE OF CULTURE(S) FOR THE ORGANISMS YOU HAVE HAD ISSUES WITH? WOUND AND BLOOD. DO YOU USE AN AP FOR SETUP OR DO YOU SET UP PANELS MANUALLY? AP. HAS AP CONTAMINATION BEEN RULED OUT? YES. WHAT IS THE INOCULUM DENSITY USED? 0.5. MANUAL SETUP SPECIFIC: NA. ARE YOUR CALIBRATORS IN DATE? YES. HOW LONG DO BROTHS SIT PRIOR TO PANEL INOCULATION? LESS THAN 30 MIN. HOW LONG AFTER PANEL INOCULATION ARE PANELS LOADED ONTO INSTRUMENT? LESS THAN 30 MIN. DO YOU USE A PHOENIX 100 OR M50? M50. WHAT IS THE SN OF YOUR PHOENIX? (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62061 | BD PHOENIX¿ PMIC/ID-107 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON, DICKINSON & CO. (SPARKS) | 448607 | 1266643 | 30382904486076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |