MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-20 for IMMAGE IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[15779161]
On (b)(4) 2012, customer reported that sample syringe was leaking on the immage 800 system. No injuries were reported and no erroneous patient results were generated. Field service engineer (fse) inspected the instrument and replaced the reagent syringe valve. This resolved the issue and no further issues were reported.
Patient Sequence No: 1, Text Type: D, B5
[15940540]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00524 |
| MDR Report Key | 2461693 |
| Report Source | 05,06 |
| Date Received | 2012-02-20 |
| Date of Report | 2012-02-01 |
| Date of Event | 2012-02-01 |
| Date Mfgr Received | 2012-02-01 |
| Device Manufacturer Date | 2009-08-17 |
| Date Added to Maude | 2012-08-21 |
| 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 SOUTH 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 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2012-02-20 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| ID Number | SOFTWARE 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 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-20 |