MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-18 for ELECSYS 2010 LABORATORY ANALYZER 2010 RACK & DISK 1804014,1568248 manufactured by Roche Diagnostics.
| Report Number | 1823260-1999-00002 |
| MDR Report Key | 207163 |
| Report Source | 05 |
| Date Received | 1999-01-18 |
| Date of Report | 1999-01-15 |
| Date of Event | 1998-12-12 |
| Date Mfgr Received | 1999-01-15 |
| Date Added to Maude | 1999-01-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS 2010 LABORATORY ANALYZER |
| Generic Name | LABORATORY IMMUNOASSAY ANALYZER |
| Product Code | LCI |
| Date Received | 1999-01-18 |
| Model Number | 2010 RACK & DISK |
| Catalog Number | 1804014,1568248 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201079 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | ELECSYS 2010 LABORATORY ANALYZER |
| Baseline Generic Name | LABORATORY IMMUNOASSAY ANALYZER |
| Baseline Model No | 2010 RACK & DIS |
| Baseline Catalog No | 1804014,1568248 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-01-18 |