MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for API? NH TEST STRIP 10400 manufactured by Biomerieux, Sa.
[140005697]
A customer in (b)(6) reported a non conforming quality control strain in association with the api? Nh (neisseria gonorrhoeae) test strip (lot 100678088). The customer stated that their qc organism (haemophilus influenzae atcc? 10211) was conforming on a previous lot of api test strips, but not on lot 1006780880. The customer then tested a new atcc? 10211 qc organism and lot 100678088 was not conforming. The customer switched to a different api nh lot and the issue was resolved. The atcc? 10211 qc strain is used to perform comprehensive quality control to demonstrate positive and negative reactivity with apnh. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615754-2019-00010 |
| MDR Report Key | 8345218 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-04-02 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2018-09-12 |
| Date Added to Maude | 2019-02-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME, LES GROTTES ISERE 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | API? NH TEST STRIP |
| Generic Name | API? NH TEST STRIP |
| Product Code | JTO |
| Date Received | 2019-02-15 |
| Catalog Number | 10400 |
| Lot Number | 1006780880 |
| Device Expiration Date | 2019-05-22 |
| 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 | 3 ROUTE DE PORT MICHAUD LA BALME, LES GROTTES ISERE 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |