MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-16 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[21765024]
Customer stated that the wash station overflowed when attempted to wash the probe on the immage 800 immunochemistry systems. Leaking hardware component could potentially impact sample results by either contamination or dilution effect. The customer was wearing personal protective equipment (ppe) consisting of a lab coat and gloves. The customer did not come in contact with the fluid and did not seek medical attention. No exposure (sprayed or splashed) to mucous membranes or open wounds were reported. No death, injury or changes to patient treatment or results are associated with this event. The customer reviewed the msds and the facility has an exposure control or risk management plan in place. On (b)(6) 2012, a field service engineer ((fse) found sample probe wash station overflowed due to clogged waste filter. The fse replaced the filter which resolved issue. The cause of the leak was due to clogged waste filter.
Patient Sequence No: 1, Text Type: D, B5
[21924542]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01072 |
| MDR Report Key | 2575541 |
| Report Source | 05,06 |
| Date Received | 2012-05-16 |
| Date of Report | 2012-04-17 |
| Date of Event | 2012-04-17 |
| Date Mfgr Received | 2012-04-17 |
| Device Manufacturer Date | 2008-09-05 |
| Date Added to Maude | 2012-09-24 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | CFN |
| Date Received | 2012-05-16 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 2012-05-16 |