MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-05 for API? RAPIDEC? CARBA NP 417824 manufactured by Biomerieux, Sa.
[137022566]
A customer in the united states contacted biom? Rieux to report a false negative result for a klebsiella pneumonia isolate in association with the rapidec? Carba np product. The customer stated they tested the klebsiella pneumonia isolate twice with microscan; the result indicated a possible carbapenem resistant enterobacteriaceae (cre). Testing with rapidec carba np provided a "negative" result. The result provided to the physician was "cre with carba np test negative". The patient isolate was sent to an external laboratory for further testing because the customer remained suspicious of cre. Pcr testing was performed = positive for oxa 48 carbapenemase. The report to physician was modified that pcr testing was cre positive. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health. Biom? Rieux requested strain submittal from the customer. Biom? Rieux investigation will be conducted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615754-2019-00006 |
| MDR Report Key | 8304917 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-05 |
| Date of Report | 2019-05-10 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2017-02-23 |
| Date Added to Maude | 2019-02-05 |
| 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 |
| 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 | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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 | API? RAPIDEC? CARBA NP |
| Generic Name | RAPIDEC? CARBA NP |
| Product Code | PTJ |
| Date Received | 2019-02-05 |
| Catalog Number | 417824 |
| Lot Number | 1005739620 |
| Device Expiration Date | 2019-02-23 |
| Device Availability | N |
| 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 | 2019-02-05 |