MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-12-30 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[2373459]
The affiliate reported the customer alleged the sample probe wash station overflowed and did not drain involving immage 800 immunochemistry system. Fluid leaked onto the top of the unit. Stopping and resetting the system did not resolve the issue. Beckman coulter customer technical support (cts) advised the customer to turn the unit off and reboot. The customer stated a complete shutdown and reboot appeared to have resolved the issue. No patient samples were run prior to or during the event. No patient results were generated. There was no injury or adverse affect associated with this event. The unit was in operation.
Patient Sequence No: 1, Text Type: D, B5
[9680655]
The customer contacted beckman coulter, inc. On (b)(4) 2011 and stated the same issue returned. Beckman coulter customer technical support (cts) assisted the customer to replace the sample valve over the telephone. The customer confirmed the unit was in operation with no further issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08496 |
| MDR Report Key | 2392794 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-30 |
| Date of Report | 2011-12-01 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2011-12-01 |
| Device Manufacturer Date | 2009-11-11 |
| Date Added to Maude | 2012-07-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-12-30 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-12-30 |