BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2022-00125
- Event Type
- Injury
- Date Received
- May 5, 2022
- Date of Event
- March 17, 2022
- Report Date
- May 24, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PATIENT¿S BIRTHDAY WAS NOT PROVIDED, XXXX-01-01 WAS USED BASED ON AGE OF PATIENT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO ADDITIONAL TESTING IS REQUIRED AT THIS TIME. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.
IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A MOLECULAR TEST INDICATED THE PRESENCE OF ALTERNATIVE PATHOGENS. CONFIRMATORY TESTING WAS PERFORMED USING GRAM STAINING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 04/26/2022 AND ADDITIONAL INFORMATION. BLOOD CULTURES DETECTED AS POSITIVE BY THE SYSTEM ARE IMMEDIATELY SMEARED AND BACTERIOSCOPY PERFORMED USING THE GRAM METHOD. THOSE IN WHICH THE PRESENCE OF GRAM-POSITIVE COCCI (GGC) IS EVIDENCED WITHIN A PERIOD OF LESS THAN 24 HOURS FROM THE MOMENT OF COLLECTION OR THAT PRESENT GRAM-NEGATIVE RODS (GNB) ARE IMMEDIATELY REFERRED TO THE BCID2 PANEL. IN OUR CURRENT ROUTINE, THE BCID2 PANEL KIT WAS RECEIVED IN NOVEMBER 2021 AND READILY AVAILABLE FOR USE. ON (B)(6), 2021, WE HAD THE FIRST FALSE POSITIVE CASE FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND SINCE THEN WE HAVE OBSERVED AN INCREASING NUMBER OF RESULTS THAT DETECTED THE MICROORGANISM, BUT THEY WERE NOT RECOVERED IN TRADITIONAL CULTURES. WE OBSERVED A TOTAL OF 15 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, ALL WITH MORE THAN ONE MICROORGANISM DETECTED. THERE WERE 13 GRAM (B)(6) BACTERIA RESULTS, ONE WITH GRAM POSITIVE AND ONE WITH AN ASSOCIATION BETWEEN THE TWO. 1ST CASE FEMALE PATIENT, 42 YEARS OLD, HOSPITALIZED IN THE DERMATOLOGY SECTION WITH A HISTORY OF HEPATIC ABSCESS WITH ESCHERICHIA COLI ISOLATION IN FEBRUARY. BLOOD CULTURE WAS COLLECTED ON (B)(6), 2022, POSITIVEFOR BACTEC ON (B)(6), 2022 AND BCID2 FILMARRAY PERFORMED AND POSITIVEFOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND E. COLI. IN VIEW OF THE RESULT, THE MEDICAL TEAM STARTED TREATING THE PATIENT WITH MEROPENEM, POLYMYXIN B AND VANCOMYCIN. ON (B)(6), IDENTIFICATION AND ANTIBIOGRAM OF THE GROWN CULTURE WERE PERFORMED, AND ONLY E. COLI WAS IDENTIFIED. ALSO ON (B)(6), THE ANTIBIOGRAM (SENSITIVE TO ALL TESTED ANTIMICROBIALS) WAS RELEASED INTO THE SYSTEM. WITH THE RESULT RELEASED, THE MEDICAL TEAM SUSPENDED VANCOMYCIN BUT KEPT POLYMYXIN B AND MEROPENEM. AFTER A VISIT BY THE CCIH AND LABAC AND THE DISCUSSION OF THE CASE/RESULT ABOUT THE FALSE POSITIVE, THE USE OF POLYMYXIN WAS SUSPENDED. CONTAMINATION BY NON-VIABLE MICROORGANISMS OF THE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX IN BD FLASKS.
IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A MOLECULAR TEST INDICATED THE PRESENCE OF ALTERNATIVE PATHOGENS. CONFIRMATORY TESTING WAS PERFORMED USING GRAM STAINING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 04/26/2022: INITIAL REPORT AND ADDITIONAL INFORMATION. BLOOD CULTURES DETECTED AS POSITIVE BY THE SYSTEM ARE IMMEDIATELY SMEARED AND BACTERIOSCOPY PERFORMED USING THE GRAM METHOD. THOSE IN WHICH THE PRESENCE OF GRAM-POSITIVE COCCI (GGC) IS EVIDENCED WITHIN A PERIOD OF LESS THAN 24 HOURS FROM THE MOMENT OF COLLECTION OR THAT PRESENT GRAM-NEGATIVE RODS (GNB) ARE IMMEDIATELY REFERRED TO THE BCID2 PANEL. IN OUR CURRENT ROUTINE, THE BCID2 PANEL KIT WAS RECEIVED IN NOVEMBER 2021 AND READILY AVAILABLE FOR USE. ON NOVEMBER 5, 2021, WE HAD THE FIRST FALSE POSITIVE CASE FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND SINCE THEN WE HAVE OBSERVED AN INCREASING NUMBER OF RESULTS THAT DETECTED THE MICROORGANISM, BUT THEY WERE NOT RECOVERED IN TRADITIONAL CULTURES. WE OBSERVED A TOTAL OF 15 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, ALL WITH MORE THAN ONE MICROORGANISM DETECTED. THERE WERE 13 GRAM NEGATIVE BACTERIA RESULTS, ONE WITH GRAM POSITIVE AND ONE WITH AN ASSOCIATION BETWEEN THE TWO. 1ST CASE - FEMALE PATIENT, 42 YEARS OLD, HOSPITALIZED IN THE DERMATOLOGY SECTION WITH A HISTORY OF HEPATIC ABSCESS WITH ESCHERICHIA COLI ISOLATION IN FEBRUARY. BLOOD CULTURE WAS COLLECTED ON MARCH 16, 2022, POSITIVE FOR BACTEC ON MARCH 17, 2022 AND BCID2 FILMARRAY PERFORMED AND POSITIVE FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND E. COLI. IN VIEW OF THE RESULT, THE MEDICAL TEAM STARTED TREATING THE PATIENT WITH MEROPENEM, POLYMYXIN B AND VANCOMYCIN. ON MARCH 18, IDENTIFICATION AND ANTIBIOGRAM OF THE GROWN CULTURE WERE PERFORMED, AND ONLY E. COLI WAS IDENTIFIED. ALSO ON MARCH 18, THE ANTIBIOGRAM (SENSITIVE TO ALL TESTED ANTIMICROBIALS) WAS RELEASED INTO THE SYSTEM. WITH THE RESULT RELEASED, THE MEDICAL TEAM SUSPENDED VANCOMYCIN BUT KEPT POLYMYXIN B AND MEROPENEM. AFTER A VISIT BY THE CCIH AND LABAC AND THE DISCUSSION OF THE CASE/RESULT ABOUT THE FALSE POSITIVE, THE USE OF POLYMYXIN WAS SUSPENDED. CONTAMINATION BY NON-VIABLE MICROORGANISMS OF THE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX IN BD FLASKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1679440 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442023 | 1167767 | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention |