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 2017-08-10 for VITEK? 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT 21346 manufactured by Biomerieux, Inc.
[83307944]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[83307945]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of neisseria gonorrhoeae as neisseria cinerea in association with the vitek? 2 neisseria-haemophilus (nh) identification (id) test kit. Due to suspicion of neisseria gonorrhoeae based on gram stain and clinical presentation, the customer performed pcr testing and obtained the neisseria gonorrhoeae result. The customer stated the discrepant vitek? 2 nh id result was not reported to the treating physician; the pcr result was used by the physician for treatment decisions. There was no adverse impact on the patient's state of health due to the discrepant result. Culture submittal was requested by biom? Rieux for internal investigation. However, the customer stated the strain is no longer viable for testing. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00258 |
| MDR Report Key | 6784344 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-10 |
| Date of Report | 2017-10-23 |
| Date Mfgr Received | 2017-09-26 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2017-08-10 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 NH ID TEST KIT |
| Product Code | JST |
| Date Received | 2017-08-10 |
| Catalog Number | 21346 |
| Lot Number | 245398920 |
| Device Expiration Date | 2017-11-15 |
| 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 | 2017-08-10 |