MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for VITEK? 2 NH ID TEST KIT 21346 manufactured by Biomerieux, Inc.
[67398397]
A customer in (b)(6) reported to biom? Rieux a misidentification in association with the vitek 2 nh id test kit. The ureteral sample is from a (b)(6) patient with no antibiotherapy. The strain was isolated from chocolate agar and tested three times with vitek 2 nh id which identified the isolate as of (b)(6). The (b)(6) identification was obtained by pcr and mass spectrometry in another laboratory. There is no indication or report from the customer that the discrepant result led to any adverse event related to the patient's state of health. The customer did report a delay in reporting results by a "few days. " the test reports were requested from the customer. An internal biom? Rieux investigation has been initiated
Patient Sequence No: 1, Text Type: D, B5
[74609698]
A customer reported a misidentification of (b)(6) on the vitek? 2 nh id test card the isolate and nh id cards were submitted by the customer for evaluation. An investigation was conducted. The isolate was subcultured on chocolate medium. One (1) vitek? 2 nh card from the customer lot (2450061203) and one (1) nh card from a random lot (245381020) were tested. The results were compared with those from full 16s sequencing, vitek? Ms and api nh strip test. The reference method (sequencing full 16s) was used to determine the intended result. Vitek? Ms and api nh strip were in favor of the species (b)(6). On vitek? 2, the nh card for both lots, gave an excellent identification to the species (b)(6). In conclusion, the customer result was not reproduced. The vitek? 2 nh id cards performed as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00051 |
| MDR Report Key | 6322068 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-04-19 |
| Date Mfgr Received | 2017-03-21 |
| Date Added to Maude | 2017-02-10 |
| 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 | 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 NH ID TEST KIT |
| Generic Name | VITEK? 2 NH ID TEST KIT |
| Product Code | JST |
| Date Received | 2017-02-10 |
| Catalog Number | 21346 |
| Lot Number | 2450061203 |
| Device Expiration Date | 2018-01-26 |
| 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 | 2017-02-10 |