MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-20 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[2108086]
A customer contacted beckman coulter, inc. (bec) to report a fluid leak under immage 800 immunochemistry system. The customer stated the leak was under the instrument near sample wheel area. Msds was not reviewed, but the facility has exposure control plan. There was no exposure to uncovered wounds or mucous membranes. No injury was reported. Medical attention was not sought and there was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[9137581]
Service visited the site on (b)(4) 2011 and found a tubing under syringe was loose. The field service engineer (fse) tightened the loose syringe and the issue was resolved. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03238 |
| MDR Report Key | 2168809 |
| Report Source | 06 |
| Date Received | 2011-07-20 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-06-17 |
| Date Mfgr Received | 2011-06-17 |
| Device Manufacturer Date | 2005-06-06 |
| Date Added to Maude | 2012-04-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 | 2011-07-20 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SW 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 | 2011-07-20 |