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 2017-06-30 for ETEST? AMPICILLIN AM 256 WW S30 412253 manufactured by Biomerieux, Sa.
[78984405]
A customer from (b)(6) reported to biomerieux false susceptible ampicillin results in association with etest? Ampicillin am 256 ww s30. The customer reported that they compared results of patient enterococcus faecalis strains for etest? And disk diffusion methods. The customer stated that ten (10) strains of the forty-one (41) tested were susceptible with etest? Ampicillin and resistant with disk diffusion. The internal qc (e. Faecalis atcc 29212) for disk diffusion was in the range according to eucast but outside for etest? (0. 38mg/l for a target 0. 5 - 2. 0). The customer reported that patient results were not affected as disk diffusion was used as first line and there was no report of patient treatment being affected. There was no delay for reporting patient results. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00153 |
| MDR Report Key | 6682549 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-30 |
| Date of Report | 2018-01-11 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2016-10-11 |
| Date Added to Maude | 2017-06-30 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| 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 | ETEST? AMPICILLIN AM 256 WW S30 |
| Generic Name | ETEST? AMPICILLIN |
| Product Code | JWY |
| Date Received | 2017-06-30 |
| Catalog Number | 412253 |
| Lot Number | 1005224490 |
| ID Number | 03573026376710 |
| Device Expiration Date | 2019-10-11 |
| 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 | 2017-06-30 |