MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,study report with the FDA on 2019-01-16 for RAPIDEC? CARBA NP 415418 manufactured by Biomerieux, Sa.
[135023550]
During literature review performed by biom? Rieux, false negative (false susceptible) results were noted for tests performed with rapidec? Carba np (ref 415418) in the article "detection of carbapenemases with a newly developed commercial assay using matrix assisted laser desorption ionization-time of flight" by ellionor rapp, orjan samuelsen, martin sundqvist. The articles claims a low sensitivity rate for detection of carbapenemase with the rapidec carba np test. The tests performed were part of a study. Therefore, there was no patient testing associated with the results, and there is no adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615754-2019-00003 |
| MDR Report Key | 8253140 |
| Report Source | FOREIGN,LITERATURE,STUDY |
| Date Received | 2019-01-16 |
| Date of Report | 2019-03-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-01-16 |
| 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 | 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 | 3 |
| Brand Name | RAPIDEC? CARBA NP |
| Generic Name | RAPIDEC? CARBA NP |
| Product Code | PTJ |
| Date Received | 2019-01-16 |
| Catalog Number | 415418 |
| 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 | 2019-01-16 |