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 2016-08-08 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[51457481]
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 rhizobium radiobacter. Confirmatory testing identified the organism as acinetobacter. 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
[58087717]
An investigation into a mis-identification event while using the vitek? Gn test kit was performed. The customer obtained a result of acinetobacter sp. As rhizobium radiobacter. The customer returned the patient strain involved in this event. Testing by vitek? Ms and id32gn confirmed the organism to be acinetobacter johnsonii. It is to be noted that acinetobacter johnsonii is not within the knowledge base of the gram negative test kit on vitek? 2. The customer strain was tested on retain samples from lots 241377140, 241377540, and 242383840. Lots 241377140 and 241377540 were customer lots involved in this event and lot 242383840 is a random lot. Results from this testing was a low discrimination between acinetobacter lwoffi and neisseria animaloris/zoodegmatis. The misidentification observed by the customer was not duplicated. Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00088 |
| MDR Report Key | 5854477 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-08 |
| Date of Report | 2016-07-08 |
| Date Mfgr Received | 2016-07-08 |
| Date Added to Maude | 2016-08-08 |
| 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 | 2016-08-08 |
| Catalog Number | 21341 |
| Lot Number | 241377140 |
| Device Expiration Date | 2017-04-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-08-08 |