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 2018-04-03 for RAPIDEC CARBA NP 415418 manufactured by Biomerieux Sa.
[104192544]
A customer in (b)(6) notified biom? Rieux of false negative results associated with rapidec carba np (reference 415418). The customer reported false negative results for rapidec carba np twice on two (2) strains for two (2) different patients while the cnrs confirmed that it was carbapenemases. The patient returned from gabon, and was treated with surgical management (digestive) with antibiotics (non carbapenems). There was a delay >24 hours in treatment due to the confirmation by the cnr. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00051 |
| MDR Report Key | 7392395 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-03 |
| Date of Report | 2018-06-13 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2017-08-22 |
| Date Added to Maude | 2018-04-03 |
| 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 RD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383 |
| Manufacturer Country | FR |
| 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 | 2018-04-03 |
| Catalog Number | 415418 |
| Lot Number | 1005914480 |
| Device Expiration Date | 2019-04-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 383 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-03 |