MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-20 for UNICEL? DXC 600 PRO SYNCHRON? CHEMISTRY ANALYZER A11810 manufactured by Beckman Coulter, Inc..
[1802951]
A customer contacted beckman coulter inc (bci) in regards to erroneously low total protein results generated by unicel dxc 600 pro synchron chemistry analyzer. The erroneous results were reported out of the laboratory. The customer noticed the low results and repeated all patient samples since the last good qc on an alternate instrument. Seven patient results were amended. The customer does not believe that patients were impacted by the erroneous results.
Patient Sequence No: 1, Text Type: D, B5
[8975671]
Qc did not demonstrate an issue. A bci field service engineer (fse) identified sample probe carryover, and replaced sample probe and wash collar. The fse performed alignments, and a retest passed specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01236 |
| MDR Report Key | 1903791 |
| Report Source | 05 |
| Date Received | 2010-11-20 |
| Date of Report | 2010-11-19 |
| Date of Event | 2010-10-22 |
| Date Mfgr Received | 2010-10-22 |
| Device Manufacturer Date | 2006-05-16 |
| Date Added to Maude | 2012-01-11 |
| 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 600 PRO SYNCHRON? CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMSTRY ANALYZER |
| Product Code | CEK |
| Date Received | 2010-11-20 |
| Model Number | DXC 600 PRO |
| Catalog Number | A11810 |
| 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 | 2010-11-20 |