MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-31 for UNICEL DXC 600 PRO SYNCHRON SYSTEM A11810 manufactured by Beckman Coulter.
[5599641]
Customer reported the unicel dxc 600 pro synchron system generated erratic and suppressed results for blood urea nitrogen (bun) for patient and quality control samples. Customer also reported reagent probe a was leaking. Customer reported the leak was about 15ml and contained to under the home position of the reagent probe a. No erroneous bun results were reported out of the lab and no change in treatment or harm to patients. No exposure reported. Customer was wearing gloves.
Patient Sequence No: 1, Text Type: D, B5
[13099053]
A field service engineer (fse) was dispatched to evaluate the instrument. Fse determined the cause of the erratic and suppressed bun patient and qc results as well as the reagent probe a leak was from reagent probe a collar wash valve. Service replaced the collar wash valve and that resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2015-00115 |
| MDR Report Key | 4646552 |
| Report Source | 05,06 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-07 |
| Date of Event | 2015-03-07 |
| Date Mfgr Received | 2015-03-07 |
| Device Manufacturer Date | 2007-06-25 |
| Date Added to Maude | 2015-05-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7142649714 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821800 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 8000 |
| 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 SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | CDN |
| Date Received | 2015-03-31 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 5.3 |
| 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 CA 92821800 US 92821 8000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-31 |