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 2018-11-19 for ETEST? MEROPENEM MP 32 WW B30 513800 manufactured by Biomerieux, Sa.
[129331356]
A customer in (b)(6) reported a false susceptible meropenem result for a klebsiella pneumoniae external quality control sample ((b)(4), specimen (b)(6)) in association with etest? Meropenem mp 32 ww b30. The customer repeated the etest three times and reported a susceptible (mic=1. 5) result, when the expected was resistant. (mc=16). The isolate was also tested on the vitek? Ast-n350 card in which meropenem was resistant (mic>=16). There was no patient involvement as the event pertained to a quality survey sample. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00243 |
| MDR Report Key | 8087135 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-19 |
| Date of Report | 2019-02-05 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2018-11-19 |
| 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 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? MEROPENEM MP 32 WW B30 |
| Generic Name | ETEST? MEROPENEM MP 32 WW B30 |
| Product Code | JWY |
| Date Received | 2018-11-19 |
| Catalog Number | 513800 |
| Lot Number | 1004872950 |
| 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 | 2018-11-19 |