MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-16 for UNICEL? DXC 800 PRO SYNCHRON? CLINICAL SYSTEMS A11812 manufactured by Beckman Coulter Inc..
[1917493]
A customer contacted beckman coulter inc. (bci) regarding a false high salicylate (saly) result generated by the unicel dxc 800 pro synchron clinical systems for one patient. The initial saly result of 217. 1mg/l was reported out of the lab. The physician questioned the result because the patient did not take any salicylate. The customer poured off the sample, re-spun and reran the sample and the result yielded <40mg/l. Patient treatment was not affected. The physician did not believe the false result.
Patient Sequence No: 1, Text Type: D, B5
[9222741]
Sample was collected in serum separator tube. Qc was run before and after the event and the results were within established ranges. A field service engineer (fse) inspected the instrument and found the collar wash stuck with gel. The fse replaced the sample probes and collar wash, performed alignments and obstruction detection. The fse instructed the customer regarding minimum tube volume, and to inspect the tube prior to loading on the instrument. The fse also noted that this is on-going training issue with training this lab.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00600 |
| MDR Report Key | 2021220 |
| Report Source | 07 |
| Date Received | 2011-03-16 |
| Date of Report | 2011-02-15 |
| Date of Event | 2011-02-14 |
| Date Mfgr Received | 2011-02-15 |
| Device Manufacturer Date | 2007-08-30 |
| Date Added to Maude | 2012-01-31 |
| 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 BLVD. |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CLINICAL SYSTEMS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKJ |
| Date Received | 2011-03-16 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| 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 | 2011-03-16 |