MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-12 for FILMARRAY ? BLOOD CULTURE IDENTIFICATION (BCID) PANEL RFIT-ASY-0126 manufactured by Biofire Diagnostics, Llc.
[138795240]
Investigation: (b)(6) reported a discrepant meca result on the filmarray bcid panel after testing a blood sample from a (b)(6) year old, male patient. The patient is a diabetic and alcoholic, and at the time of sample collection (date unknown), the patient was critically ill with acute kidney injury (aki) (scr was 6. 83 mg/dl with a baseline of 0. 85 mg/dl). The patient was not on antimicrobial treatment at the time of sample collection. The sample was cultured using a bact/alert sa bottle (lot# 1052254; expiration date october 17, 2019). The sample was tested on the filmarray bcid panel on (b)(6) 2019, and the result was (b)(6) for enterococcus, streptococcus, (b)(6), and meca. Based on the filmarray bcid panel result, the patient was treated with vancomycin. On (b)(6) 2019, the sample was tested again on the filmarray bcid panel. The result was the same as the first filmarray bcid panel test: (b)(6) for enterococcus, streptococcus, (b)(6), and meca. A gram stain was performed using the sample and resulted in gram positive cocci. A culture was also performed using the sample and the culture grew enterococcus faecalis, streptococcus species, and (b)(6). The (b)(6) was identified by a manual coagulase test and mic was performed on vitek. The mic results reported (b)(6). The vancomycin treatment was discontinued after the culture results were available. Due to the filmarray bcid result, the customer reported that the patient was on vancomycin unnecessarily for several days (exact timeframe unknown). The customer stated that the unnecessary treatment "likely did not help" the patient's condition, and thus may have caused the patient harm. Based on the information submitted, it cannot be determined if the vancomycin was responsible for the injury, or increased the severity of the injury, and if the positive blood cultures were clinically significant or should have been considered as contaminated. Biofire has reached out to the customer to request additional information regarding this case. Quality control (qc) records for both the initial and repeat filmarray bcid panel tests (pouch lot# 381218 and kit lot# 0500618) were reviewed. This pouch lot passed the qc criteria and was found within specifications. No run malfunction was observed and the filmarray instrument (serial # (b)(4)) was working within design specifications. Conclusion: based on the information provided at this time, the investigation concluded that the most likely cause for the discrepant filmarray bcid panel meca result is differences in sensitivity between the filmarray bcid panel and comparator methods. (b)(6) can be a heterogeneous population consisting of both (b)(6). (b)(6) can be missed when only a single colony or only a few colonies are selected for antimicrobial susceptibility testing. The sample could also contain slow-growing strains of (b)(6) that required extended incubation to detect the presence of (b)(6). Additionally, as per vitek2 product recall notice (#z-2817-2018), it is advised to use the bioart rule and do additional confirmatory testing by either meca pcr or pbp2a testing. The filmarray bcid panel reports detections from the blood culture population, while vitek and manual coagulase testing report detections from a single/few isolated colonies. Additionally, the results for the filmarray bcid panel antimicrobial resistance gene assays do not specifically link the resistance gene to the associated organism. Specifically, in mixed growth, the filmarray bcid panel does not attribute meca-mediated (b)(6) to either (b)(6) or other staphylococcus species. Therefore, the positive meca result on the filmarray bcid panel could be due to multiple staphylococcus organisms present in the sample. During panel performance evaluation, the bcid meca assay showed robust performance as compared to pcr/sequencing of cultured isolates of (b)(6), with a sensitivity of 98. 5% (ci 91. 7-100%) and a specificity of 95. 6% (ci 87. 6-99. 1%) for prospective fresh specimens. When compared with phenotypic automated ast testing, the bcid meca assay performed well in samples containing (b)(6) with a ppa of 97. 7% (ci 93. 4-99. 5%) and npa of 96. 7% (ci 91. 7-99. 1%) (bcid panel instruction booklet [https://www. Online-ifu. Com/iti0045]). It is important to note that the filmarray bcid panel is indicated as an aid in the diagnosis of specific agents of bacteremia and fungemia, and results should be used in conjunction with other clinical and laboratory findings. It is also important to note that the performance of the filmarray bcid panel has not been evaluated specifically on immunocompromised patients (bcid panel instruction booklet [https://www. Online-ifu. Com/iti0045]).
Patient Sequence No: 1, Text Type: N, H10
[138795241]
(b)(6) reported a discrepant meca result on the filmarray blood culture identification (bcid) panel after testing a blood sample from a (b)(6) year old, immunocompromised, male patient. Due to the filmarray bcid result, the customer reported that the patient was given unnecessary treatment for several days. The customer also reported that the unnecessary treatment may have caused harm to the patient. Upon investigation, no malfunction occurred and the system was working within specifications. The investigation concluded the discrepancy was most likely caused by specificity differences between the filmarray bcid panel and comparator methods, possibly in combination with a sample contained a heterogenous population of resistant and susceptible staphylococci.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002773840-2019-00002 |
| MDR Report Key | 8414780 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-12 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2018-12-31 |
| Date Added to Maude | 2019-03-12 |
| 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 | KRISTEN KANACK |
| Manufacturer Street | 515 COLOROW DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84108 |
| Manufacturer Country | US |
| Manufacturer Postal | 84108 |
| Manufacturer Phone | 8017366354 |
| Manufacturer G1 | BIOFIRE DIAGNOSTICS, LLC |
| Manufacturer Street | 515 COLOROW DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILMARRAY ? BLOOD CULTURE IDENTIFICATION (BCID) PANEL |
| Generic Name | FILMARRAY ? BLOOD CULTURE IDENTIFICATION (BCID) PANEL |
| Product Code | PEN |
| Date Received | 2019-03-12 |
| Model Number | RFIT-ASY-0126 |
| Catalog Number | RFIT-ASY-0126 |
| Lot Number | 0500618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFIRE DIAGNOSTICS, LLC |
| Manufacturer Address | 515 COLOROW DRIVE SALT LAKE CITY UT 84108 US 84108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-12 |