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 2017-01-23 for VITEK? 2 GN ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[65523693]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[65523694]
A customer in (b)(6) contacted biom? Rieux to report inconsistent organism identification in association with the vitek? 2 gram-negative (gn) identification (id) test kit. For the same strain, initial result was aeromonas hydrophilia/caviae and repeat test obtained aeromonas sobria. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. Culture submittal has been requested by biom? Rieux for internal investigation. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[71637751]
A customer in (b)(6) contacted biom? Rieux to report inconsistent organism identification in association with the vitek? 2 gn test kit. The customer submitted the isolates for evaluation. An investigation was conducted. The two submitted isolates were subcultured and gn card testing included individual organism suspensions on two cards from each of the implicated lots and two cards from a random lot. Api 20ne was also performed. Isolate 911267 (01bc1639369): five of the six gn cards tested, resulted in excellent identifications of aeromonas sobria. The remaining card gave a low discrimination identification of aeromonas hydrophila/caviae/sobria. The api20ne resulted in a very good identification 99% aeromonas sobria. For this isolate, the misidentification was not reproduced and cards are performing as expected. Isolate 911268 (01bc1643526): four of the six gn cards tested resulted in excellent identifications of aeromonas sobria. The remaining two cards, both from lot 241379410, resulted in excellent identifications of aeromonas hydrophila/caviae, reproducing the customer's results. The api20ne resulted in a very good identification 99% aeromonas sobria. These species are closely related. Review of the aeromonas hydrophila/caviae data against expected reactions for aeromonas sobria demonstrated one atypical positive reaction (ggt) contributing to the misidentification. A review of quality records confirmed gn lots 241379410 and 241386540 both met the criteria for qc performance testing and final release. In conclusion, a misidentification for one isolate was not reproduced and the second isolate was an atypical strain. The vitek? 2 gn cards performed as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00029 |
| MDR Report Key | 6269694 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-23 |
| Date of Report | 2017-03-27 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2016-05-04 |
| Date Added to Maude | 2017-01-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 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 ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | JTO |
| Date Received | 2017-01-23 |
| Catalog Number | 21341 |
| Lot Number | 241379410 |
| Device Expiration Date | 2017-05-04 |
| 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 | 2017-01-23 |