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 2018-06-20 for ETEST? BENZYLPENICIL PG 32 WW S30 412265 manufactured by Biomerieux Sa.
[112445502]
A customer from (b)(6) reported discrepant results in association with the etest? Benzylpenicil pg 32 ww s30 (lot 1005850850), when compared to their reference lab results. The customer stated that the discrepant results involved patient isolates and that quality control strains had no problems. The customer reported that they are seeing a high discrepancy rate for isolates that are at the penicillin meninginitis break point (i. E. 0. 06) or higher. The customer confirmed the patient results were delayed and also erroneous results were reported to the physician. The customer stated they would not provide patient details at this time. The customer stated they are testing in house and sending to a reference lab, so erroneous results would have been amended within a few days. There is no indication or report from the hospital or treating physician to biom? Rieux that any discrepant result led to any adverse event related to a patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00083 |
| MDR Report Key | 7619754 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-20 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2018-12-14 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2018-06-20 |
| 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. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | 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 | ETEST? BENZYLPENICIL PG 32 WW S30 |
| Generic Name | ETEST? BENZYLPENICIL PG 32 WW S30 |
| Product Code | JWY |
| Date Received | 2018-06-20 |
| Catalog Number | 412265 |
| Lot Number | 1005850850 |
| 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 | 2018-06-20 |