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 2018-11-01 for ETEST? IMIPENEM IP 32WW S30 412374 manufactured by Biomerieux, Sa.
[127360116]
A customer in (b)(6) reported false resistant imipenem results for pseudomonas aeruginosa isolates in association with etest? Imipenem ip 32ww s30 (lot 1006022690). In (b)(6) 2018, the customer initially reported false results with vitek? Cards, when performing a study for a diploma thesis, on different techniques with ast testing. The customer stated the initial test was with a patient urine sample on a vitek 2 ast-n248 card, and that other tests for the study included the vitek 2 ast-n196, bd phoenix, etest and disk diffusion. The investigation for the vitek cards, concluded that the customer's etest results were false resistant compared to broth microdilution. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00227 |
| MDR Report Key | 8030587 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-11-01 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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? IMIPENEM IP 32WW S30 |
| Generic Name | ETEST? IMIPENEM IP 32WW S30 |
| Product Code | JWY |
| Date Received | 2018-11-01 |
| Catalog Number | 412374 |
| Lot Number | 1006022690 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-01 |