MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-05 for UNICEL DXC 600 SYNCHRON SYSTEM A10405 manufactured by Beckman Coulter.
[56544005]
A beckman coulter field service engineer (fse) evaluated the instrument and replaced a solenoid valve to resolve the issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[56544006]
The customer reported to beckman coulter hotline that the unicel dxc 600 synchron system generated false high dign (digoxin) results of 2. 6 and 2. 7 ng/ml on one emergency room (er) patient sample. It is unknown which one these results was reported outside of the lab. The customer stated there was no impact to patient treatment based on the reported high dign result. Additionally, alt, ast and bun (alanine aminotransferase, aspartate aminotransferase and blood urea nitrogen) results were suppressed (no results generated) on this same sample. Controls (qc) were run before and after this event and the results met the laboratory's established ranges. The customer repeated the original sample and the dign result was lower (<0. 1 ng/ml). A redraw sample was also tested and confirmed to be <0. 1 ng/ml. The customer corrected the result to the lower obtained value.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2016-00314 |
| MDR Report Key | 6000903 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-05 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2011-07-07 |
| Date Added to Maude | 2016-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 928218000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXC 600 SYNCHRON SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | KXT |
| Date Received | 2016-10-05 |
| Model Number | NA |
| Catalog Number | A10405 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA 928218000 US 928218000 |
| Brand Name | UNICEL DXC 600 SYNCHRON SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JJE |
| Date Received | 2016-10-05 |
| Model Number | NA |
| Catalog Number | A10405 |
| Lot Number | NA |
| 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 BLVD BREA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-05 |