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 2017-07-13 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux, Inc.
[80040014]
A customer from (b)(6) reported to biom? Rieux a misidentification of an urethral sample as neisseria meningitides in association with the vitek? 2 nh test kit. The customer suspected the isolate was a pathogenic bacteria. The customer stated the isolate was cultured using chocolate agar polyvitex vcat 3 under co2 atmosphere. Suspect colonies were observed and tested on the vitek? 2 nh card which gave a result of neisseria meningitides (95%). The test was repeated with subcultured colonies from haemophilus chocolate 2 agar (haem) and the result was neisseria cinerea (99%). A gram stain and oxidase test was not performed. There was a positive dglu reaction on the neisseria meningitides result. The customer reported the issue did not impact the medical provider or patient. 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. Biom? Rieux requested the customer repeat the test but the strain was no longer available. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00214 |
| MDR Report Key | 6712485 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-13 |
| Date of Report | 2017-09-28 |
| Date Mfgr Received | 2017-09-05 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2017-07-13 |
| 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 | 2017-07-13 |
| Catalog Number | 21346 |
| Lot Number | 2450075203 |
| ID Number | 03573026144357 |
| Device Expiration Date | 2018-02-09 |
| 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 | 2017-07-13 |