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 2012-11-09 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[20357684]
A customer reported to beckman coulter, inc. (bec) that the immage 800 immunochemistry system was leaking wash buffer. The leak was approximately 2 ml and was contained within the instrument. The customer changed buffer filter but the issue persisted. The customer was wearing gloves and eye protection at the time of the event. There was no report of injury or exposure and medical attention was not sought. Msds was not reviewed, but the facility has an exposure control or risk management plan in place. No erroneous patient results were generated. Bec field service engineer (fse) visited the site on (b)(4) 2012 and noted an obstruction in the sample wash station. The fse cleared the obstruction and cleaned the sample wash station.
Patient Sequence No: 1, Text Type: D, B5
[20599935]
Results: obstruction in the sample wash station. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01816 |
| MDR Report Key | 2826006 |
| Report Source | 01,05,06 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-15 |
| Date of Event | 2012-10-15 |
| Date Mfgr Received | 2012-10-15 |
| Device Manufacturer Date | 2009-11-11 |
| Date Added to Maude | 2013-02-15 |
| 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 | 2012-11-09 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SOFTWARE V. 2.0.1.0 |
| 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 | 2012-11-09 |