MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-08 for UNICEL? DXC 600 PRO SYNCHRON? ACCESS? CLINICAL SYSTEM A11810 manufactured by Beckman Coulter.
[22190366]
A customer contacted beckman coulter (bec) reporting that the unicel dxc 600 pro synchron chemistry analyzer generated four (4) false low sodium (na) patient results on two (2) different days ((b)(6) 2013). This report documents the false na patient result generated on (b)(6) 2013. The false low result was not reported out of the laboratory. When the issue was noticed, the sample was repeated on an alternate instrument in the laboratory and that result was reported. The customer indicated that only na results were affected in this event. The results provided by the customer are shown in this report. Patient treatment was not impacted from this event.
Patient Sequence No: 1, Text Type: D, B5
[22336426]
Quality control (qc) prior to the event was low and exhibited the issue. However, the lab-established range is wide, and the qc fell within range. A bec field service engineer (fse) was dispatched and noted that the flowcell was dirty and found a bubble on the face of the na electrode. The fse replaced the electrode and cleaned the flowcell. Mdr 2050012-2013-00326 is related to this event and documents the false low na results obtained on (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00327 |
| MDR Report Key | 3100566 |
| Report Source | 05,06 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-04-09 |
| Date of Event | 2013-04-06 |
| Date Mfgr Received | 2013-04-09 |
| Device Manufacturer Date | 2006-03-03 |
| Date Added to Maude | 2013-07-15 |
| 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 DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 PRO SYNCHRON? ACCESS? CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | NGS |
| Date Received | 2013-05-08 |
| Model Number | DXC 600 PRO |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID Number | SW VERSION 4.9.02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-08 |