MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-12-04 for IMMAGE IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter Inc..
[2274206]
The customer reported to the customer technical support (cts) that immage 800 instrument intermittently drops liquid on cover between sample probe wash well and sample wheel. The customer verified the tightness of all connection including draw tube, syringes and probe; no issues were noted. Patient results were not impacted by this event and no erroneous results were generated. The customer did not come in contact with the fluid. On (b)(6) 2011, a field service engineer (fse) performed the following: replaced the sample probe and performed all probe alignments. Ordered a new xcaliber 180? T-valve for the customer. The customer ran qc and no issues were noted by the fse
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2011-08229 |
| MDR Report Key | 2357170 |
| Report Source | 01,06 |
| Date Received | 2011-12-04 |
| Date of Report | 2011-11-03 |
| Date of Event | 2011-11-03 |
| Date Mfgr Received | 2011-11-03 |
| Device Manufacturer Date | 2010-11-17 |
| Date Added to Maude | 2012-07-20 |
| 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 | MRS DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-12-04 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | N/A |
| ID Number | SW 2.0.10 |
| 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 | 2011-12-04 |