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 2011-09-22 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter Inc..
[20954188]
Customer called reporting that the sample probe wash station of an immage 800 immunochemistry system had overflowed and was leaking wash buffer down into the instrument on (b)(6) 2011. Customer also stated that bubbles were seen in the sample and reagent syringes. Customer technical support instructed the customer to check the external drain hose for blockage but no crimped or blocked tubing was found. No erroneous results were generated or reported out of the lab.
Patient Sequence No: 1, Text Type: D, B5
[21226711]
Field service engineer replaced the sample probe drain valve on (b)(6) 2011 and no further leaking was observed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05566 |
| MDR Report Key | 2260840 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-22 |
| Date of Report | 2011-08-26 |
| Date of Event | 2011-08-26 |
| Date Mfgr Received | 2011-08-26 |
| Device Manufacturer Date | 2009-08-12 |
| Date Added to Maude | 2012-06-05 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 | 2011-09-22 |
| 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 | 2011-09-22 |