MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-03 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[17126530]
A customer reported to beckman coulter, inc. (bec) that the immage 800 immunochemistry system leaked a clear and odorless fluid from the sample drain under the probe. The fluid dripped onto the floor. The customer was wearing gloves and eye protection when the leak was discovered. There was no report of injury or exposure, and medical attention was not sought. Msds was not reviewed, but the facility has an emergency chemical spill plan in place. No erroneous patient results were generated. Bec field service engineer (fse) observed a sample probe wash station overflow. The fse replaced both wash station waste filters and the cuvette wash station waste filter. Service activity performed was verified per established procedures, and the results met published performance specifications.
Patient Sequence No: 1, Text Type: D, B5
[17351711]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01896 |
| MDR Report Key | 2855139 |
| Report Source | 05,06 |
| Date Received | 2012-12-03 |
| Date of Report | 2012-11-07 |
| Date of Event | 2012-11-07 |
| Date Mfgr Received | 2012-11-07 |
| Device Manufacturer Date | 2010-01-29 |
| Date Added to Maude | 2013-03-08 |
| 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 | 2012-12-03 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SOFTWARE V. 2.0.10 |
| 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 | 2012-12-03 |