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 2017-06-01 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux, Inc.
[76603492]
A customer from (b)(6) reported to biom? Rieux a misidentification of neisseria gonorrhoeae as neisseria cineria in association with the vitek? 2 nh test kit. The customer reported the vitek? 2 nh card result was neisseria cineria (99%). The customer stated the test was performed from martin lewis agar (bd) and gc agar (bd), and the plate was incubated for 18-24 hours with co2. A gram stain was performed and specific diplococci-like neisseria gonorrhoeae was observed. Testing with api? Nh produced a result of neisseria species, and the specific api? Profile test was still in process at the time of reporting. Pcr testing gave a result of neisseria gonorrhoeae, however this testing was from an agar plate, which is not the valid test method. The customer repeated the testing of isolates on martin lewis agar, and reported that isolates incubated less than 24 hours were not identified by vitek? 2 as expected. The last isolate with incubation time of 24 hours, produced two kinds of colonies, a small and a larger one. The vitek? 2 identification for the small and large colonies was slashline and neisseria gonorrhoeae, respectively. The customer reported incorrect results were not reported to a physician and there was no impact to patient results or treatment. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00169 |
| MDR Report Key | 6606077 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-01 |
| Date of Report | 2017-12-18 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2016-06-10 |
| Date Added to Maude | 2017-06-01 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 NH TEST KIT |
| Generic Name | VITEK? 2 NH TEST CARD |
| Product Code | JST |
| Date Received | 2017-06-01 |
| Catalog Number | 21346 |
| Lot Number | 2450014203 |
| ID Number | 03573026144357 |
| Device Expiration Date | 2017-12-10 |
| 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 ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-01 |