MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-01-11 for UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEM A27318 manufactured by Beckman Coulter Inc..
[16567507]
No qc issues were noted. A field service engineer (fse) was on-site and replaced the cartridge chemistry sample probe and mixer wash station. Repairs were verified and the issue was resolved. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
[16642023]
Customer contacted beckman coulter inc. (bci) regarding false high triglyceride (tg) results generated by the unicel dxc 600i synchron access clinical system. The original results were in the range 415-923 mg/dl and upon repeat the results were in the range 108-285 mg/dl. There were no long-term consequences for the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2010-00004 |
| MDR Report Key | 1574481 |
| Report Source | 05 |
| Date Received | 2010-01-11 |
| Date of Report | 2009-01-12 |
| Date of Event | 2009-12-18 |
| Date Mfgr Received | 2009-12-18 |
| Device Manufacturer Date | 2008-06-12 |
| Date Added to Maude | 2010-07-01 |
| 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 | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 200 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92822 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDT |
| Date Received | 2010-01-11 |
| Model Number | NA |
| Catalog Number | A27318 |
| Lot Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 200 S. KRAEMER BLVD. BREA CA 92822 US 92822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-11 |