MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-01 for ARIOL SL-200 SCANNING SYSTEM manufactured by Leica Biosystems Richmond, Inc..
[5923933]
Customer reported the following issues with the ariol sl-200 scanning system: persistent inconsistencies in frame illumination (changes in color and brightness) in the same scan. Inconsistency in the count number of target events. Variability in overall brightness between different scans.
Patient Sequence No: 1, Text Type: D, B5
[13416422]
The device is still under investigation. Follow up report will be sent upon receipt of additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419341-2015-00002 |
| MDR Report Key | 4810849 |
| Report Source | 05 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-04-30 |
| Date of Event | 2015-04-30 |
| Date Mfgr Received | 2015-04-30 |
| Device Manufacturer Date | 2012-12-18 |
| Date Added to Maude | 2015-06-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSEPH CONSOLI |
| Manufacturer Street | 5205 ROUTE 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARIOL SL-200 SCANNING SYSTEM |
| Generic Name | NONE |
| Product Code | NTH |
| Date Received | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS RICHMOND, INC. |
| Manufacturer Address | RICHMOND |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-01 |