MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-31 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter Inc..
[2517277]
Customer called on (b)(6) 2012 reporting of a leak coming from the sample probe of an immage 800 immunochemistry system. Customer stated that the instrument was serviced the day before the incident and all qc and patient samples were good when the field service engineer (fse) had left the site. Customer stated that no patient samples were run and no erroneous results were generated as a result of the leak. Customer was wearing personal protective equipment at the time of the leak and no exposure or injury was reported. Fse returned on 01/13/2012 and replaced the sample syringe assembly with a new assembly. Issue was resolved and repair was verified as per established procedure.
Patient Sequence No: 1, Text Type: D, B5
[9589103]
Evaluation - results: fse returned the sample syringe assembly. (b)(4)..
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00312 |
| MDR Report Key | 2433877 |
| Report Source | 05,06 |
| Date Received | 2012-01-31 |
| Date of Report | 2012-01-12 |
| Date of Event | 2012-01-12 |
| Date Mfgr Received | 2012-01-12 |
| Device Manufacturer Date | 2004-07-20 |
| Date Added to Maude | 2012-08-10 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 | JQX |
| Date Received | 2012-01-31 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| 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 | 2012-01-31 |