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 2016-08-05 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[51344859]
A customer notified biomerieux of a mis-identification when using the vitek? 2 gram negative id test kit. The vitek? 2 test kit identified the organism as aeromonas sobria. Confirmatory testing identified te organism as e. Coli. When specifically asked the customer noted no injury or death happened as a result of this incident. The customer did indicate a delay in results of greater than 24 hours as a result of this event. An investigation has been initiated by biomerieux to investigate this event.
Patient Sequence No: 1, Text Type: D, B5
[58727546]
An investigation into a mis-identification event while using the vitek 2 gn id test kit was performed. The customer reported that a misidentification of the strain escherichia coli as aeromonas sobria obtained with gn card. The customer submitted the patient sample for investigative testing. The sample was tested using the vitek ms instrument and identified the organism as e. Coli. The organism was subcultured on cba media and tested on 2 gn cards: customer lot 241376840 (cl) and a random lot 241377310 (rl). The results between the lots were compared. A low discrimination between e. Coli/e. Coli 0. 157/vibrio cholera was obtained on the customer lot; however, the oxydase test was negative so, in favor of e. Coli. Nevertheless, the customer misidentification to the species aeromonas sobria was duplicated on the random lot. The biochemical profile of the isolate was analyzed and it was determined to be atypical. Based on the results of the investigation, the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00087 |
| MDR Report Key | 5851701 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-05 |
| Date of Report | 2016-07-07 |
| Date Mfgr Received | 2016-07-07 |
| Date Added to Maude | 2016-08-05 |
| 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 | 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 | 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 GRAM NEGATIVE ID TEST KIT |
| Generic Name | VITEK? 2 GRAM NEGATIVE ID TEST KIT |
| Product Code | LRH |
| Date Received | 2016-08-05 |
| Catalog Number | 21341 |
| Lot Number | 241376840 |
| Device Expiration Date | 2017-04-08 |
| 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 | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-05 |