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 2017-03-29 for ETEST? ERTAPENEM ETP 32 WW B30 531600 manufactured by Biomerieux, Sa.
[71222232]
A customer from austria reported to biom? Rieux a false susceptible ertapenem result for an enterobacter cloacae complex, external quality control sample ((b)(4)), in association with etest? Ertapenem etp 32 ww b30. The customer reported the etest? Result was out of range low (mic 0. 5 ug/ml) and the expected result was resistant (mic > = 2 ug/ml). The sample was tested with vitek? 2 and the result was mic 2 ug/ml. Testing with the disc method produced a result of 20 mm. As the issue occurred during external quality control testing, there was no patient involvement. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00057 |
| MDR Report Key | 6443992 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-29 |
| Date of Report | 2017-06-30 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2014-11-12 |
| Date Added to Maude | 2017-03-29 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| 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? ERTAPENEM ETP 32 WW B30 |
| Generic Name | ETEST? ERTAPENEM ETP 32 WW B30 |
| Product Code | JWY |
| Date Received | 2017-03-29 |
| Catalog Number | 531600 |
| Lot Number | 1003569060 |
| ID Number | 03573026249380 |
| Device Expiration Date | 2017-09-28 |
| 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 | 2017-03-29 |