MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-01-05 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[64020087]
A customer from the united states reported to biom? Rieux a misidentification of escherichia coli as salmonella sp. In association with vitek? 2 gn id test kit. Initial and repeat testing of the isolate with the vitek? 2 gn identified salmonella sp. (95%). The isolate was taken from a mac plate, incubated >/=18hrs non-co2, and was indole positive, h2s negative. The customer sent the isolate to a state laboratory for identification and was tested with maldi-tof which identified escherichia coli. The customer then tested the isolate with api? 20e test strip which gave an identification to genus e. Coli 1 (84. 1%) and e. Coli 2 (15. 8%). There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[70671023]
A biom? Rieux investigation was conducted for a misidentification of escherichia coli as salmonella sp. In association with vitek? 2 gn test kit. The customer submitted two lab reports. The bottom of both lab reports were cut off so some well results and the software version is missing from the report. Lab report from (b)(6) 2016 showed a very good identification of salmonella spp. Five (5) well reactions were cut off the lab report but the remaining well results showed five (5) atypical negative reactions (glya, agal, bgal, phos, bgur). Lab report from (b)(6) 2016 showed a very good identification of salmonella spp. Seven (7) well reactions were cut off the lab report but the remaining well results showed four (4) atypical negative reactions (agal, bgal, phos, bgur). A review of quality records confirmed gn lot 241396710 met the final quality control release criteria. Escherichia coli and salmonella are closely related species. Any identification of salmonella should be confirmed with another method such as serology. The vitek? 2 gn lab report prints the message "confirm by serological tests" for any identification of salmonella. The customer confirmed the identification by sending it to their state laboratory. An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. The submitted isolate exhibits an atypical biochemical profile. Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00001 |
| MDR Report Key | 6226245 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-05 |
| Date of Report | 2017-03-21 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-01-05 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 GN TEST KIT |
| Generic Name | VITEK? 2 GN TEST CARD |
| Product Code | JTO |
| Date Received | 2017-01-05 |
| Catalog Number | 21341 |
| Lot Number | 241396710 |
| Device Expiration Date | 2017-10-24 |
| 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 | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-05 |