MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-06-16 for BACT/ALERT? BPN CULTURE BOTTLE 279045 manufactured by Biomerieux, Inc.
[47600310]
A customer in (b)(6) notified biom? Rieux of a false negative result associated with bact/alert? Bpn culture bottle (reference (b)(4)) involving quality control strain coryne amycolatum (atcc 49368). The customer indicated the bottle was incubated for seven (7) days, but the strain was not detected with the bact/alert?. After seven (7) days of incubation, they streaked the strain on culture media and obtained growth of coryne amycolatum. The customer retested, but obtained the same result. The customer indicated buying a brand new strain of coryne amycolatum and performed the test using the same lot of the bact/alert? Bpn culture bottles and there was no detection, but growth on media after seven (7) days of incubation. The customer denied patient impact. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[55233606]
An investigation into a false negative event while using the bact/alert? Bpn culture bottle was performed. The bact/alert? Bpn bottle failed to flag positive and grow a qc-strain of corynebacterium amycolatum. The investigation examined the bact/alert? Bpn eu lot 3044709 manufacturing directions, including the quality control release testing documentation and all results were within specification. A review of the customer procedure was analyzed. The customer notated they incubate the bottles at 22 c. Additionally, the customer used a bottle designed to isolate anaerobic organisms with an organism that is well known to be aerobic. Therefore, the most probable root cause was determined to be culture bottle/medium and incubation temperature that does not support the growth of the organism. C. Amycolatum is an aerobic organism and was attempted to be recovered in an anaerobic bottle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00105 |
| MDR Report Key | 5730061 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-16 |
| Date of Report | 2016-04-15 |
| Date Added to Maude | 2016-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? BPN CULTURE BOTTLE |
| Generic Name | BACT/ALERT? BPN CULTURE BOTTLE |
| Product Code | MZC |
| Date Received | 2016-06-16 |
| Catalog Number | 279045 |
| Lot Number | 3044709 |
| Device Expiration Date | 2016-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-16 |