MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-27 for AU480 CLINICAL CHEMISTRY ANALYZER AU481-10E, CHEMISTRY ANALYZER AU480 WITH ISE B12183 manufactured by Beckman Coulter.
| Report Number | 9612296-2020-00110 |
| MDR Report Key | 9889987 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-26 |
| Date Facility Aware | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2020-03-27 |
| 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 | MR. HARRY LONG |
| Manufacturer Street | 1000 LAKE HAZELTINE DR. M/S R590C |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681224 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO NAGAIZUMI-CHO SUNTO-GUN |
| Manufacturer City | SCHIZUOKA JP-NOTA 4 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | JP-NOTA 41 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU480 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JJE |
| Date Received | 2020-03-27 |
| Model Number | AU481-10E, CHEMISTRY ANALYZER AU480 WITH ISE |
| Catalog Number | B12183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |