MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-07 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[2173341]
A customer reported to beckman coulter, inc. (bec) that a fluid leak was observed from back of immage 800 immunochemistry system. Msds was not reviewed, but the facility has an exposure control plan. The operator did not seek medical attention and there was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[9292067]
On (b)(4) 2011, field service engineer (fse) found all cuvettes overflowing with wash solution. The fse replaced drain filter, and cleaned all cuvettes. The fse performed wash cuvettes with no flooding, but cuvettes started to flood again upon qc run. The fse found the waste filter was blocked with gel substance inside filter, and replaced the filter and wash probe. The fse performed alignments with new cuvettes in place. The fse also replaced all other filters for both wash stations and hydro. The fse rebooted the instrument and performed wash cuvettes with no flooding. Sample wash station started to overflow. The fse replaced both wash station waste valves, controller 2 board and controller 1 board due to flooding from cuvette wash probe. The fse washed all cuvettes three times, and primed the system five times with no issues. The fse ran qc for all chemistries 2 times. No issue was noted and all qc results were within the established ranges. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05045 |
| MDR Report Key | 2237275 |
| Report Source | 05,06 |
| Date Received | 2011-09-07 |
| Date of Report | 2011-08-08 |
| Date of Event | 2011-08-08 |
| Date Mfgr Received | 2011-08-08 |
| Device Manufacturer Date | 2008-08-19 |
| Date Added to Maude | 2012-05-25 |
| 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 | 2011-09-07 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SW 1.6 |
| 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 | 2011-09-07 |