MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-18 for UNICEL? DXC 800 PRO SYNCHRON? CLINICAL SYSTEM DXC800 PRO A11812 manufactured by Beckman Coulter, Inc..
[1830205]
A customer contacted beckman coulter inc. (bci) in regards to erroneously low phosphorous (phosm) results generated by unicel dxc 800 pro synchron clinical system for 43 patients. Fourteen results were reported out of the laboratory and amended before patient treatment was impacted.
Patient Sequence No: 1, Text Type: D, B5
[8882916]
Qc and calibration results were acceptable prior to the event. The instrument would not calibrate for phosm after the event. A bci field service engineer (fse) replaced the phosm module.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01604 |
| MDR Report Key | 1932490 |
| Report Source | 05 |
| Date Received | 2010-12-18 |
| Date of Report | 2010-11-18 |
| Date of Event | 2010-11-18 |
| Date Mfgr Received | 2010-11-18 |
| Device Manufacturer Date | 2009-06-22 |
| Date Added to Maude | 2011-06-07 |
| 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 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CLINICAL SYSTEM |
| Generic Name | CLINICAL CHEMSTRY ANALYZER |
| Product Code | CEO |
| Date Received | 2010-12-18 |
| Model Number | DXC800 PRO |
| Catalog Number | A11812 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2010-12-18 |