MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-22 for ICHEM? VELOCITY? AUTOMATED URINE CHEMISTRY SYSTEM 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING U 700-7177-001 manufactured by Beckman Coulter.
| Report Number | 2122870-2019-01113 |
| MDR Report Key | 8923233 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-22 |
| Date of Report | 2019-09-26 |
| Date of Event | 2019-07-23 |
| Date Facility Aware | 2019-07-23 |
| Date Mfgr Received | 2019-08-27 |
| Date Added to Maude | 2019-08-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DR. |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM? VELOCITY? AUTOMATED URINE CHEMISTRY SYSTEM |
| Generic Name | AUTOMATED URINALYSIS SYSTEM |
| Product Code | KQO |
| Date Received | 2019-08-22 |
| Model Number | 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING U |
| Catalog Number | 700-7177-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS, CO CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-22 |