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 2017-09-01 for VITEK? 2 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT 21346 manufactured by Biomerieux Inc..
[86008590]
Device not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10
[86008591]
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. Repeat testing provided a low discrimination identification to n neisseria gonorrhoea / neisseria meningitidis. Due to suspicion of neisseria gonorrhoeae based on the appearance of the isolated colonies, the customer sent the isolate to a reference laboratory. The reference laboratory obtained identification neisseria gonorrhoeae via pcr testing and vitek? 2 nh id card. 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. 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 | 1950204-2017-00291 |
| MDR Report Key | 6837680 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-01 |
| Date of Report | 2017-11-06 |
| Date Mfgr Received | 2017-10-10 |
| Device Manufacturer Date | 2017-04-28 |
| Date Added to Maude | 2017-09-01 |
| 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 | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| 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 NEISSERIA-HAEMOPHILUS (NH) IDENTIFICATION (ID) TEST KIT |
| Generic Name | VITEK? 2 NH ID CARD |
| Product Code | JST |
| Date Received | 2017-09-01 |
| Catalog Number | 21346 |
| Lot Number | 2450336203 |
| Device Expiration Date | 2018-10-28 |
| 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 | 2017-09-01 |