MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-21 for STARLIMS CLINICAL SOLUTION CL10.07 manufactured by Abbott Informatics Corporation.
| Report Number | 3006130047-2019-00001 |
| MDR Report Key | 8917790 |
| Date Received | 2019-08-21 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-07-17 |
| Date Mfgr Received | 2019-07-22 |
| Device Manufacturer Date | 2013-06-28 |
| Date Added to Maude | 2019-08-21 |
| 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. LINDA RYAN |
| Manufacturer Street | 4000 HOLLYWOOD BLVD SUITE 333 S |
| Manufacturer City | HOLLYWOOD FL 33021 |
| Manufacturer Country | US |
| Manufacturer Postal | 33021 |
| Manufacturer G1 | ABBOTT INFORMATICS CORPORATION |
| Manufacturer Street | 4000 HOLLYWOOD BLVD SUITE 333 S |
| Manufacturer City | HOLLYWOOD FL 33021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STARLIMS CLINICAL SOLUTION |
| Generic Name | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, |
| Product Code | JQP |
| Date Received | 2019-08-21 |
| Model Number | CL10.07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT INFORMATICS CORPORATION |
| Manufacturer Address | 4000 HOLLYWOOD BLVD SUITE 333 S HOLLYWOOD FL 33021 US 33021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-21 |