MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-08-01 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[2735124]
A customer reported to beckman coulter, inc. (bec) that the cuvettes on immage 800 immunochemistry system were overflowing during the cuvette wash operation. The customer stated that patient results have been reported out, but did not provide any details. The customer indicated the samples were run on another immage system and the results were different. It is unknown if there were any changes to patient treatment attributed or connected to this event. The operator was wearing gloves and lab coat. The operator did not seek medical attention, and no injury was reported. A field service engineer (fse) visited the site on (b)(4) 2012. The fse checked wash head, wash line filter, and vacuum pump. The fse replaced wash line filter, waste canister filter, and all cuvettes. The fse aligned wash head and cranes. The fse ran calibration and controls. The issue was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-01631 |
| MDR Report Key | 2678467 |
| Report Source | 01,05,06 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-11 |
| Date of Event | 2012-07-11 |
| Date Mfgr Received | 2012-07-11 |
| Device Manufacturer Date | 2008-03-18 |
| Date Added to Maude | 2012-11-23 |
| 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 | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2012-08-01 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SOFTWARE V. 2.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-01 |