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 2020-01-02 for BACT/ALERT? PF PLUS (PLASTIC) - 410853 manufactured by Biomerieux Inc..
[187517970]
The device was not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[187517973]
A customer in (b)(6) notified biomerieux of a false positive enterobacteriaceae result when testing an infant blood culture sample using the bact/alert? Pf plus blood culture bottle (ref. 410853, lot 4052717) in conjunction with the biofire? Filmarray? Instrument. The customer confirmed the patient was an infant with an extensive intra-abdominal surgical history and was known to have esbl colonization. The customer also confirmed the patient had two sets of blood culture testing using lot 4052717. Set one (1) was pulled from a scalp vein and set two (2) was taken from a broviac line culture. The bact/alert? Pf plus bottles from both sets flagged positive on the instrument and were then tested on the filmarray(lot 678019). The filmarray results for both sets were enterobacteriaceae and staphylococcus aureus detected. The subculture result for both bact/alert? Pf plus bottles grew only staphylococcus aureus. The patient also had a third blood culture tested using a different lot (lot not specified) of bact/alert? Pf plus bottles. This bottle also was positive and tested on filmarray(lot 678019). From this blood culture, the filmarray detected only staphylococcus aureus. The customer stated the filmarray result delayed rationalization of broad spectrum antibiotics with prolonged meropenem treatment. The root cause for false positive enterobacteriaceae result obtained by the customer when using the filmarray identification panel is associated with the presence of an increased level of nucleic acid from non-viable enterobacteriaceae and escherichia coli in the biom? Rieux bact/alert? Pf plus bottle. The presence of non-viable organism does not compromise the intended function of the blood culture bottles (culturing viable microorganisms). However, the biofire bcid panel detects nucleic acid from both viable and non-viable organisms. A field safety corrective action was issued by biofire diagnostics on 19-mar-2019 because of an increased rate of false positive enterobacteriaceae and escherichia coli results using the filmarray bcid panel with specific types of biom? Rieux blood culture bottles. A field safety notice was sent to customers informing about the issue and instructing them to confirm positive results for escherichia coli and enterobacteriaceae by an alternative method prior to reporting the test results. Although there is no indication or report from the laboratory that the discrepant result led to any direct negative impact to the patient's state of health, the customer stated the patient received prolonged meropenem treatment due to the filmarray result delaying rationalization of broad spectrum antibiotics. Biom? Rieux will initiate an internal investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2020-00001 |
| MDR Report Key | 9540865 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-01-01 |
| Date Added to Maude | 2020-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER ARMSTRONG |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145068201 |
| 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 |
| Removal Correction Number | 4292 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? PF PLUS (PLASTIC) - 410853 |
| Generic Name | BACT/ALERT? PF PLUS (PLASTIC) - 410853 |
| Product Code | MDB |
| Date Received | 2020-01-02 |
| Catalog Number | 410853 |
| Lot Number | 4052717 |
| Device Expiration Date | 2019-12-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-02 |