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 2018-06-20 for ETEST? ITRACONAZOLE 525858 manufactured by Biomerieux Sa.
[112571794]
A customer in the united states notified biom? Rieux of out of range low results for internal quality controls (qc) in association with etest? Itraconazole (reference 525858). The customer reported that at 24 hours they had a mic value of 0. 016 on multiple test strips. At 48 hours the customer reported test results of 0. 032. The customer has tested the same lot of strips with multiple lots of organisms and media. The customer ordered another order of strips, and received the same lot. They tested the new kit of etest? Strips and received similar results. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00086 |
| MDR Report Key | 7620578 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-20 |
| Date of Report | 2018-08-20 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2017-02-16 |
| 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. TIFFANY HALL |
| 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 383, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? ITRACONAZOLE |
| Generic Name | ETEST? ITRACONAZOLE |
| Product Code | NGZ |
| Date Received | 2018-06-20 |
| Catalog Number | 525858 |
| Lot Number | 1005507630 |
| 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 383, FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-20 |