MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-26 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[2833312]
A customer contacted beckman coulter, inc. (bec) to report a fluid leak under immage 800 immunochemistry system. The customer discovered a puddle of fluid underneath the instrument while running qc. Qc results were acceptable, but the customer stopped running the instrument. No erroneous patient results were generated. The operator was wearing gloves and lab coat, and made no direct skin contact while cleaning up the puddle. Msds was not reviewed, but the facility has exposure control plan. The operator did not seek medical attention, and no injury was reported. A field service engineer (fse) visited the site and identified a loose fitting on the syringe manifold. The fse secured the fitting to resolve the issue. Service activity performed was verified to meet the specified requirements per established procedures.
Patient Sequence No: 1, Text Type: D, B5
[10049787]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01630 |
| MDR Report Key | 2671837 |
| Report Source | 05,06 |
| Date Received | 2012-07-26 |
| Date of Report | 2012-07-09 |
| Date of Event | 2012-07-09 |
| Date Mfgr Received | 2012-07-09 |
| Device Manufacturer Date | 2012-04-05 |
| Date Added to Maude | 2012-11-16 |
| 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. 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 | 2012-07-26 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | NA |
| 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 | 2012-07-26 |