MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-08 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter Inc..
[21751678]
Customer called on (b)(4) 2011 reporting that the wash well of an immage 800 immunochemistry system was overflowing due to low vacuum errors. Customer noted that before obtaining low vacuum errors, qc was within established ranges and no erroneous results were generated. Field service engineer (fse) was dispatched on (b)(4) 2011 and rebuilt the vacuum pump and replaced the filters for the vacuum system.
Patient Sequence No: 1, Text Type: D, B5
[21926295]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07353 |
| MDR Report Key | 2327814 |
| Report Source | 05,06 |
| Date Received | 2011-11-08 |
| Date of Report | 2011-10-13 |
| Date of Event | 2011-10-13 |
| Date Mfgr Received | 2011-10-13 |
| Device Manufacturer Date | 2006-09-26 |
| Date Added to Maude | 2012-07-12 |
| 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 | 2011-11-08 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| ID Number | SW VERSION 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 | 2011-11-08 |