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 2017-10-05 for API? NH TEST STRIP 10400 manufactured by Biomerieux Sa.
[89477984]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with api nh (reference 10400). The customer reported the expected identification as neisseria sicca and the actual result was neisseria gonorrhoea 98% (good id). Repeat testing confirmed the misidentification. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00289 |
| MDR Report Key | 6917592 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-05 |
| Date of Report | 2018-02-19 |
| Date Mfgr Received | 2018-01-26 |
| Device Manufacturer Date | 2017-01-10 |
| Date Added to Maude | 2017-10-05 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | TE, 3 ROUTE DE PORT MICHAUD 38390 LA BALME-LES-GROTTES |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API? NH TEST STRIP |
| Generic Name | API? NH TEST STRIP |
| Product Code | JTO |
| Date Received | 2017-10-05 |
| Model Number | 10400 |
| Lot Number | 1005423530 |
| Device Expiration Date | 2017-09-28 |
| 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 SA |
| Manufacturer Address | TE, 3 ROUTE DE PORT MICHAUD 38390 LA BALME-LES-GROTTES FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-05 |