BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2023-00130
- Event Type
- Malfunction
- Date Received
- September 13, 2023
- Date of Event
- August 9, 2023
- Report Date
- December 7, 2023
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420215
- PMA / PMN Number
- K123903
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY CATALOG: 442021 BATCH NO.: 3130613 CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
REPORT 2 OF 6. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS 6 MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTIONS: CASE SUBJECT SHOULD SAY "FX 442021_3130613, 3109873 - MOLECULAR FALSE POSITIVES" PATIENT # 7 CORRECT LOT # IS 3130613. PATIENT 2 IS ON A DIFFERENT CASE THEREFORE THERE WERE ONLY 6 FALSE POSITIVES. PATIENT # 5 (21-YR OLD FEMALE): SEQUENCE # 446588139928 TESTED ON FT3838 BCID2, LOT # 0989923 CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN CULTURE GREW E. COLI PATIENT # 6 (30-YR OLD FEMALE): SEQUENCE # 446588139266 TESTED ON FT3837 BCID2, LOT # 0989923 CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN CULTURE GREW STAPH EPIDERMIDIS AND CO-AG NEG STAPH PATIENT # 7 (58-YR OLD FEMALE): PATIENT HARM WAS NOTED. WAS THERE ANY CHANGE IN TREATMENT? DID AN INJURY OCCUR? "NO INJURY OCCURRED. PATIENT HAS BEEN DISCHARGED" SEQUENCE # 446591480876 TESTED ON FB2266 BCID2, LOT # 0989923 CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN CULTURE GREW E. COLI PATIENT # 5 (21-YR OLD FEMALE): SEQUENCE # 446588139928 TESTED ON FT3838 BCID2, LOT # 0989923 CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN CULTURE GREW E. COLI PATIENT # 6 (30-YR OLD FEMALE): SEQUENCE # 446588139266 TESTED ON FT3837 BCID2, LOT # 0989923 CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN CULTURE GREW STAPH EPIDERMIDIS AND CO-AG NEG STAPH PATIENT # 7 (58-YR OLD FEMALE): PATIENT HARM WAS NOTED. WAS THERE ANY CHANGE IN TREATMENT? DID AN INJURY OCCUR? "NO INJURY OCCURRED. PATIENT HAS BEEN DISCHARGED" SEQUENCE # 446591480876 TESTED ON FB2266 BCID2, LOT # 0989923 CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN CULTURE GREW E. COLI DID ERRONEOUS RESULTS OCCUR? YES IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 7 MOLECULAR FPS IF YES¿WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): YES - CUSTOMER REPORTS POSSIBLE HARM TO 3 PATIENTS DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO PATIENT # 5 (LISTED AS PT #6 IN EMAIL): 21 YR OLD FEMALE W/ ABDOMINAL PAIN/ SICKLE CELL CRISIS NO HARM TO PATIENT ANAEROBIC BOTTLE LOT 3109873, EXPIRATION DATE 1/25/24 COLLECTED 8/7/23, POSITIVE 8/8/23 GST= GNRS FILMARRAY- DETECTED E.COLI AND C. TROPICALIS REPEAT - NO C. TROPICALIS DETECTED FINAL DIAGNOSIS- SEPSIS, SICKLE CELL ANEMIA FINAL REPORT TO PHYSICIAN- E. COLI PATIENT # 6 (LISTED AS PT #7 IN EMAIL): 30 YR OLD FEMALE W/ CHEST PAIN NO HARM TO PATIENT ANAEROBIC LOT # 3109873, EXPIRATION DATE 1/25/24 COLLECTION DATE: 8/2/23, POSITIVE DATE 8/2/23 GST= GPC PAIRS AND CLUSTERS FILMARRAY- STAPH EPIDERMIDIS AND C. TROPICALIS- REPORT TO PHYSICIAN- STAPH EPIDERMIDIS AND CNS- FILMARRAY - NOT REPEATED PATIENT # 7 (LISTED AS PT #8 IN EMAIL): 58 YR OLD FEMALE W/ FEVER POSSIBLE HARM TO PATIENT ANAEROBIC BOTTLE LOT 3120613, EXPIRE 2/15/24 COLLECTION DATE- 8/15/23. POSITIVE 8/15 GST= GNRS FILMARRAY - E. COLI AND C. TROPICALIS REPEAT FILMARRAY- NO C. TROPICALIS DETECTED REPORTED TO PHYSICIAN- E.COLI AND C. TROPICALIS= NOT SEEN ON GRAM STAIN, CULTURE IN PROGRESS PATIENT # 1 (LISTED AS PT #1 IN EMAIL): 70 YR OLD FEMALE SYMPTOMS- ALTERED MENTAL STATUS POSSIBLE HARM TO PATIENT. PATIENT DISCHARGED COLLECTION DATE- 8/10/23 ANAEROBIC UNABLE TO VERIFY LOT NUMBER AND EXPIRATION DATE. POSITIVE DATE- 8/10. GST= GNRS AND GPC PAIRS AND CHAINS FILMARRAY RESULT- E.COLI, STREP SPECIES, CANDIDA TROPICALIS REPEAT FILMARRAY- SAME REPORTED TO PHYSICIAN- E.COLI, PSEUDOMOMAS AERUGINOSA, AND STREP MITIS AND CANDIDA TROPICALIS FINAL DIAGNOSIS- SEPSIS, DEHYDRATION, HYPOALBUMINEMIA PATIENT # 3 (LISTED AS PT #3 IN EMAIL): 65 YR OLD MALE- GENERAL ADMIT ILLNESS NO HARM TO PATIENT ANAEROBIC 3130613 2/15/24 COLLECTION 8/8/23; POSITIVE 8/9/23 GST= GPC PAIRS AND CLUSTERS FILMARRAY DETECTED STAPH EPIDERMIDIS, CANDIDA TROPICALIS REPEAT DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS REPORT TO PHYSICIAN- STAPH EPIDERMIDIS, NO C. TROPICALIS REPORTED. PATIENT # 4 (LISTED AS PT #5 IN EMAIL): 80 YR OLD FEMALE W/ ABDOMINAL PAIN POSSIBLE HARM TO PATIENT; ANAEROBIC BOTTLE COLLECTION- 8/12/23; POSITIVE 8/13- UNABLE TO VERIFY LOT AND EXPIRATION GST- GPC PAIRS AND CLUSTERS. I WILL HAVE TO UPLOAD THE RUN FILES ON THIS PATIENT. FLIMARRAY - DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS, REPEAT C. TROPICALIS DETECTED. REPORT TO PHYSICIAN- STAPH EPIDERMIDIS AND C. TROPICALIS- DETECTED BY PCR, NOT SEEN ON GRAM STAIN, CULTURE IN PROGRESS. PATIENT # 1 (LISTED AS PT #1 IN EMAIL): 70 YR OLD FEMALE SYMPTOMS- ALTERED MENTAL STATUS POSSIBLE HARM TO PATIENT. PATIENT DISCHARGED COLLECTION DATE- 8/10/23 ANAEROBIC UNABLE TO VERIFY LOT NUMBER AND EXPIRATION DATE. POSITIVE DATE- 8/10. GST= GNRS AND GPC PAIRS AND CHAINS FILMARRAY RESULT- E.COLI, STREP SPECIES, CANDIDA TROPICALIS REPEAT FILMARRAY- SAME REPORTED TO PHYSICIAN- E.COLI, PSEUDOMOMAS AERUGINOSA, AND STREP MITIS AND CANDIDA TROPICALIS FINAL DIAGNOSIS- SEPSIS, DEHYDRATION, HYPOALBUMINEMIA PATIENT # 3 (LISTED AS PT #3 IN EMAIL): 65 YR OLD MALE- GENERAL ADMIT ILLNESS NO HARM TO PATIENT ANAEROBIC 3130613 2/15/24 COLLECTION 8/8/23; POSITIVE 8/9/23 GST= GPC PAIRS AND CLUSTERS FILMARRAY DETECTED STAPH EPIDERMIDIS, CANDIDA TROPICALIS REPEAT DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS REPORT TO PHYSICIAN- STAPH EPIDERMIDIS, NO C. TROPICALIS REPORTED. PATIENT # 4 (LISTED AS PT #5 IN EMAIL): 80 YR OLD FEMALE W/ ABDOMINAL PAIN POSSIBLE HARM TO PATIENT; ANAEROBIC BOTTLE COLLECTION- 8/12/23; POSITIVE 8/13- UNABLE TO VERIFY LOT AND EXPIRATION GST- GPC PAIRS AND CLUSTERS. I WILL HAVE TO UPLOAD THE RUN FILES ON THIS PATIENT. FLIMARRAY - DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS, REPEAT C. TROPICALIS DETECTED. REPORT TO PHYSICIAN- STAPH EPIDERMIDIS AND C. TROPICALIS- DETECTED BY PCR, NOT SEEN ON GRAM STAIN, CULTURE IN PROGRESS. HAZARD, INJURY OR ERRONEOUS RESULTS? YES DID ERRONEOUS RESULTS OCCUR? YES CUSTOMER REPORTS MULTIPLE CASES OF MOLECULAR FALSE POSITIVES
REPORT 2 OF 6. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS 6 MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTIONS: CASE SUBJECT SHOULD SAY "(B)(6)- MOLECULAR FALSE POSITIVES" PATIENT # (B)(6) CORRECT LOT # IS 3130613. PATIENT (B)(6) IS ON A DIFFERNT CASE THEREFORE THERE WERE ONLY 6 FALSE POSITIVES. PATIENT # (B)(6) (21-YR OLD FEMALE): SEQUENCE #: (B)(4). TESTED ON (B)(6), LOT # 0989923. CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN. CULTURE GREW E. COLI. PATIENT # (B)(6) (30-YR OLD FEMALE): SEQUENCE # (B)(4). TESTED ON (B)(6), LOT # 0989923. CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN CULTURE GREW STAPH EPIDERMIDIS AND CO-AG NEG STAPH PATIENT # (B)(6) (58-YR OLD FEMALE): PATIENT HARM WAS NOTED. WAS THERE ANY CHANGE IN TREATMENT? DID AN INJURY OCCUR? "NO INJURY OCCURRED. PATIENT HAS BEEN DISCHARGED." SEQUENCE #: (B)(4). TESTED ON (B)(6), LOT # 0989923. CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN. CULTURE GREW E. COLI. PATIENT # (B)(6) (21-YR OLD FEMALE): SEQUENCE # (B)(4). TESTED ON (B)(6), LOT # 0989923. CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN. CULTURE GREW E. COLI. PATIENT # 6 (30-YR OLD FEMALE): SEQUENCE # (B)(4). TESTED ON (B)(6), LOT # 0989923. CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN. CULTURE GREW STAPH EPIDERMIDIS AND CO-AG NEG STAPH. PATIENT # (B)(6) (58-YR OLD FEMALE): PATIENT HARM WAS NOTED. WAS THERE ANY CHANGE IN TREATMENT? DID AN INJURY OCCUR? "NO INJURY OCCURRED. PATIENT HAS BEEN DISCHARGED." SEQUENCE # (B)(4). TESTED ON (B)(6), LOT # 0989923. CONFIRMATORY TESTING WAS CULTURE AND GRAM STAIN. CULTURE GREW E. COLI. DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 7 MOLECULAR FPS. IF YES¿WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): YES - CUSTOMER REPORTS POSSIBLE HARM TO 3 PATIENTS. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO. PATIENT # (B)(6) (LISTED AS PT #6 IN EMAIL): 21 YR OLD FEMALE W/ ABDOMINAL PAIN/ SICKLE CELL CRISIS. NO HARM TO PATIENT. ANAEROBIC BOTTLE LOT 3109873, EXPIRATION DATE 1/25/24. COLLECTED (B)(6) 2023, POSITIVE (B)(6) 2023 GST= GNRS. FILMARRAY- DETECTED E.COLI AND C. TROPICALIS. REPEAT - NO C. TROPICALIS DETECTED. FINAL DIAGNOSIS- SEPSIS, SICKLE CELL ANEMIA. FINAL REPORT TO PHYSICIAN- E. COLI. PATIENT # (B)(6) (LISTED AS PT #(B)(6) IN EMAIL): 30 YR OLD FEMALE W/ CHEST PAIN. NO HARM TO PATIENT. ANAEROBIC LOT # 3109873, EXPIRATION DATE 1/25/24. COLLECTION DATE: (B)(6) 2023, POSITIVE DATE (B)(6) 2023. GST= GPC PAIRS AND CLUSTERS. FILMARRAY- STAPH EPIDERMIDIS AND C. TROPICALIS- REPORT TO PHYSICIAN- STAPH EPIDERMIDIS AND CNS- FILMARRAY - NOT REPEATED. PATIENT # (B)(6) (LISTED AS PT #(B)(6) IN EMAIL): 58 YR OLD FEMALE W/ FEVER. POSSIBLE HARM TO PATIENT. ANAEROBIC BOTTLE LOT 3120613, EXPIRE 2/15/24. COLLECTION DATE- (B)(6) 2023. POSITIVE (B)(6) GST= GNRS. FILMARRAY - E. COLI AND C. TROPICALIS. REPEAT FILMARRAY- NO C. TROPICALIS DETECTED. REPORTED TO PHYSICIAN- E.COLI AND C. TROPICALIS= NOT SEEN ON GRAM STAIN, CULTURE IN PROGRESS. PATIENT # (B)(6) (LISTED AS PT #1 IN EMAIL): 70 YR OLD FEMALE. SYMPTOMS- ALTERED MENTAL STATUS. POSSIBLE HARM TO PATIENT. PATIENT DISCHARGED. COLLECTION DATE- (B)(6) 2023 ANAEROBIC UNABLE TO VERIFY LOT NUMBER AND EXPIRATION DATE. POSITIVE DATE- (B)(6). GST= GNRS AND GPC PAIRS AND CHAINS. FILMARRAY RESULT- E.COLI, STREP SPECIES, CANDIDA TROPICALIS. REPEAT FILMARRAY- SAME. REPORTED TO PHYSICIAN- E.COLI, PSEUDOMOMAS AERUGINOSA, AND STREP MITIS AND CANDIDA TROPICALIS. FINAL DIAGNOSIS- SEPSIS, DEHYDRATION, HYPOALBUMINEMIA. PATIENT # (B)(6) (LISTED AS PT #(B)(6) IN EMAIL): 65 YR OLD MALE- GENERAL ADMIT ILLNESS. NO HARM TO PATIENT. ANAEROBIC 3130613 2/15/24 COLLECTION (B)(6) 2023; POSITIVE (B)(6) 2023. GST= GPC PAIRS AND CLUSTERS. FILMARRAY DETECTED STAPH EPIDERMIDIS, CANDIDA TROPICALIS. REPEAT DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS. REPORT TO PHYSICIAN- STAPH EPIDERMIDIS, NO C. TROPICALIS REPORTED. PATIENT # (B)(6) (LISTED AS PT #(B)(6) IN EMAIL): 80 YR OLD FEMALE W/ ABDOMINAL PAIN. POSSIBLE HARM TO PATIENT; ANAEROBIC BOTTLE COLLECTION- (B)(6) 2023; POSITIVE (B)(6) - UNABLE TO VERIFY LOT AND EXPIRATION. GST- GPC PAIRS AND CLUSTERS. I WILL HAVE TO UPLOAD THE RUN FILES ON THIS PATIENT. FLIMARRAY - DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS, REPEAT C. TROPICALIS DETECTED. REPORT TO PHYSICIAN- STAPH EPIDERMIDIS AND C. TROPICALIS- DETECTED BY PCR, NOT SEEN ON GRAM STAIN, CULTURE IN PROGRESS. PATIENT # (B)(6) (LISTED AS PT #1 IN EMAIL): 70 YR OLD FEMALE. SYMPTOMS- ALTERED MENTAL STATUS. POSSIBLE HARM TO PATIENT. PATIENT DISCHARGED. COLLECTION DATE- (B)(6) 23 ANAEROBIC UNABLE TO VERIFY LOT NUMBER AND EXPIRATION DATE. POSITIVE DATE- (B)(6) . GST= GNRS AND GPC PAIRS AND CHAINS. FILMARRAY RESULT- E.COLI, STREP SPECIES, CANDIDA TROPICALIS. REPEAT FILMARRAY- SAME. REPORTED TO PHYSICIAN- E.COLI, PSEUDOMOMAS AERUGINOSA, AND STREP MITIS AND CANDIDA TROPICALIS. FINAL DIAGNOSIS- SEPSIS, DEHYDRATION, HYPOALBUMINEMIA. PATIENT # (B)(6) (LISTED AS PT #3 IN EMAIL): 65 YR OLD MALE- GENERAL ADMIT ILLNESS. NO HARM TO PATIENT. ANAEROBIC 3130613 2/15/24. COLLECTION: (B)(6) 2023; POSITIVE (B)(6) 2023. GST= GPC PAIRS AND CLUSTERS. FILMARRAY DETECTED STAPH EPIDERMIDIS, CANDIDA TROPICALIS. REPEAT DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS. REPORT TO PHYSICIAN- STAPH EPIDERMIDIS, NO C. TROPICALIS REPORTED. PATIENT # (B)(6) (LISTED AS PT #5 IN EMAIL): 80 YR OLD FEMALE W/ ABDOMINAL PAIN. POSSIBLE HARM TO PATIENT; ANAEROBIC BOTTLE COLLECTION- (B)(6) 2023; POSITIVE (B)(6) - UNABLE TO VERIFY LOT AND EXPIRATION. GST- GPC PAIRS AND CLUSTERS. I WILL HAVE TO UPLOAD THE RUN FILES ON THIS PATIENT. FLIMARRAY - DETECTED STAPH EPIDERMIDIS AND C. TROPICALIS, REPEAT C. TROPICALIS DETECTED. REPORT TO PHYSICIAN- STAPH EPIDERMIDIS AND C. TROPICALIS- DETECTED BY PCR, NOT SEEN ON GRAM STAIN, CULTURE IN PROGRESS. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ERRONEOUS RESULTS OCCUR? YES. CUSTOMER REPORTS MULTIPLE CASES OF MOLECULAR FALSE POSITIVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2282810 | BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 3130613 | 00382904420215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |