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 2018-05-10 for ETEST? CEFTAZIDIME TZ 256 WW S30 412293 manufactured by Biomerieux Sa.
[108616790]
A customer in (b)(6) reported false susceptible ceftazidime (caz) results for a pseudomonas aeruginosa (atcc 27853) quality control strain, and a pseudomonas strain isolated from a patient in intensive care, in association with the etest? Ceftazidime tz 256 ww s30 (lot 1005376560). The customer stated that the caz value for the qc strain was mic= 0. 5mg/l (out of range low) instead of mic= 1-4 mg /l. A new qc strain was tested and the result was the same, mic=0. 5mg/l. The patient strain was tested twice on the impacted lot and the result was caz mic = 4mg/l. The customer also performed the broth micro dilution method and a different i2a ast test on the impacted patient strain, and obtained correlated results of mic= 16 mg/l (resistant result). The customer stated that the false result had a clinical impact on the patient, but no additional information was provided. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00065 |
| MDR Report Key | 7504475 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-10 |
| Date of Report | 2018-08-22 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2018-05-10 |
| 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 | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD 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? CEFTAZIDIME TZ 256 WW S30 |
| Generic Name | ETEST? CEFTAZIDIME TZ 256 WW S30 |
| Product Code | JWY |
| Date Received | 2018-05-10 |
| Catalog Number | 412293 |
| Lot Number | 1005376560 |
| Device Expiration Date | 2018-12-15 |
| 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 | 2018-05-10 |