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 2017-03-01 for VITEK? 2 GRAM NEGATIVE (GN) TEST KIT 21341 manufactured by Biomerieux, Inc.
[68610926]
A customer in (b)(6) notified biom? Rieux of a discrepant result associated with vitek? 2 gram negative (gn) test kit. As part of (b)(6), the customer reported the vitek? 2 gn card identified a strain as myroides instead of bergeyella zoohelcum. The customer obtained results of myroides at 98%, however, the expected result is bergeyella zoohelcum. Bergeyella zoohelcum is not part of the database for the anc cards. There is a limitation statement in the product information manual that states: "newly described or rare species may not be included in the gn database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification". However, the vitek 2 obtained an incorrect identification of myroides at 98%. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[74805786]
An internal biom? Rieux investigation was performed. The investigation was initiated due to a misidentification of bergeyella zoohelcum on eeq survey (ctcb survey qc strain ctcb 164-1642), as myroides spp. Ctcb information: identification to the species for 63. 4% of participants and to the genus for 64. 4%. The isolate was subcultured on columbia blood agar medium, and testing included vitek? 2 gn cards from the customer lot (cl:241389540) & random lot (rl: 241379810). The results were compared with sequencing full 16s used to determine the intended result. The reference method confirmed the identification to the species bergeyella zoohelcum. On vitek? 2, multiple lots of gn cards gave a low discrimination call of myroides spp/ brevundimonas diminuta/vesicularis. The misidentification to the species myroides spp obtained by the customer (low discrimination in house) was not reproduced. Bergeyella zoohelcum is not in the vitek? 2 knowledge base (kb) and there is a limitation for species not claimed in the kb: testing of unclaimed species may result in an unidentified result or a misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00075 |
| MDR Report Key | 6367645 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-01 |
| Date of Report | 2017-04-25 |
| Date Mfgr Received | 2017-03-28 |
| Date Added to Maude | 2017-03-01 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 (GN) TEST KIT |
| Generic Name | VITEK? 2 GRAM NEGATIVE (GN) TEST KIT |
| Product Code | JTO |
| Date Received | 2017-03-01 |
| Catalog Number | 21341 |
| Lot Number | 241388140 |
| Device Expiration Date | 2017-07-30 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |