MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-05-17 for BACT/ALERT FA CULTURE BOTTLE 259791 NA manufactured by Biomerieux, Inc..
[21712165]
Bact/alert fa and fn bottles did not flag positive for haemophilus parainfluenzae for blood specimens from a patient with an infection/abscess on heart mitral valve. This patient contracted endocarditis and subsequently died. Sequence of events: patient was treated with antibiotics (augmentin) for 3 days, prior to admission to hospital. Antibiotic treatment was stopped upon hospital admission and several (approx 10) blood draws were taken within a couple of days. Additional blood cultures were collected the next month and the following eighteen days. Then antibiotics (cefuroxime/gentamycin) were prescribed for respiratory insufficiency, however, this treatment was stopped the same day upon admission to intensive care. Additional samples taken within the same month, were positive for e. Coli due to colonischemy with endocarditis. The patient subsequently died. Obduction material was tested and identified haemophilus parainfluenzae, as well as e. Coli and enterococci (due to ischemy). The microbiologist claimed that had the sample flagged positive, then there would not have been a delay in the treatment for endocarditis.
Patient Sequence No: 1, Text Type: D, B5
[21822086]
Bact/alert fa/fn bottle package insert limitations indicate that certain fastidious organisms may require specialized media/culture conditions for recovery and may not grown in fa/fn bottles. Also, organisms that grow in fa/fn bottles may not produce sufficient co2 to flag positive and the presence of active antibiotics may contribute to this. In addition, certain strains of h. Influenzae may produce insufficient co2 because of insufficient amounts of sample in the fa bottle. H. Parainfluenzae is also not expected to grow in the nitrogen atmosphere fn bottle because this organism needs a 3-5% co2 environment to grow. Therefore, these fn samples would not be considered false negatives. Patient was known to be on several antibiotics prior to/during hospital stay. These antibiotics may have weakened the organism in question. Additionally, haemophilus species (h aphrophilus, paraphrophilus, parainfluenzae) are part of the hacek group of organisms that cause endocarditis and are difficult to culture. They can cause acute presentation but often cause a sub-acute presentation. They are difficult to grow and the recommendation for cases of "culture negative endocarditis" is to subculture the negative bottles to chocolate agar and incubate in co2. A high level of clinical suspicion is required. The physician should alert the lab that endocarditis is suspected and that hacek organisms are a possibility. Subacute endocarditis presentation is usually low-grade fevers, weight loss, malaise and a heart murmur. Based on the information provided for this incident, the fa bottle appears to have functioned as expected. It is just that the organism in question do not grown well in this system or any other.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00003 |
| MDR Report Key | 853183 |
| Report Source | 07 |
| Date Received | 2007-05-17 |
| Date of Report | 2007-05-09 |
| Date of Event | 2007-04-23 |
| Date Mfgr Received | 2007-04-23 |
| Date Added to Maude | 2007-05-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRIAN BRUNDIDGE, STAFF SPECIALI |
| Manufacturer Street | 100 RODOLPHE ST |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202968 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT FA CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2007-05-17 |
| Model Number | 259791 |
| Catalog Number | NA |
| Lot Number | 1013400 |
| ID Number | NA |
| Device Expiration Date | 2007-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 840798 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-05-17 |