MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for ETEST? AMIKACIN 412218 manufactured by Biomerieux Sa.
[77845874]
A customer in the united states notified biom? Rieux of discrepant quality control results associated with etest? Amikacin. The customer reported the expected results with the quality control organism pseudomonas aeruginosa atcc? 27853 to be 1-4, but the actual result was 2-8. The testing was repeated. There is no indication or report from the hospital to biom? Rieux that the daptomycin qc failure led to any adverse event related to a patient's state of health. There is no patient directly associated with the qc sample. There may be a potential for adverse event if the event were to recur while testing a patient isolate; therefore this event is being reported as a malfunction. Culture submittals have been requested by biom? Rieux for internal investigation. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00137 |
| MDR Report Key | 6645323 |
| Date Received | 2017-06-15 |
| Date of Report | 2017-08-17 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2016-05-31 |
| Date Added to Maude | 2017-06-15 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | TE, 3 ROUTE DE PORT MICHAUD 38390 LA BALME-LES-GROTTES |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ETEST? AMIKACIN |
| Generic Name | ETEST? AMIKACIN |
| Product Code | JWY |
| Date Received | 2017-06-15 |
| Model Number | 412218 |
| Lot Number | 1004907960 |
| ID Number | 03573026376567 |
| 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 | TE, 3 ROUTE DE PORT MICHAUD 38390 LA BALME-LES-GROTTES FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |