MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-18 for UNICEL DXC 800 SYNCHRON SYSTEM DXC 800 PRO A11812 manufactured by Beckman Coulter, Inc..
[20795610]
Customer called to report that the unicel dxc 800 synchron system (serial number (b)(4)) generated falsely low phosphorus results for three patients. Customer stated that the phosphorus cup was failing calibration, and that quality controls had been erratic. Customer ran samples on an alternate dxc instrument (serial number (b)(4)), the results of which varied from that of the original instrument. On the same day, the field service engineer (fse) inspected the instrument and updated the reagent syringe pump to the tricontinent pump; however, this did not resolve the issue. The fse returned on the following day to upgrade the stirrer motor to the brushless motor because the stirrer motor was hesitating and noisy. The fse then verified instrument performance to ensure that the services performed effectively resolved the leak issue. Customer stated that although erroneous results were generated, they were not reported outside the laboratory; therefore, patient treatment was not affected.
Patient Sequence No: 1, Text Type: D, B5
[20909526]
The beckman coulter, inc. Identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07621 |
| MDR Report Key | 2342627 |
| Report Source | 05,06 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-24 |
| Date of Event | 2011-10-24 |
| Date Mfgr Received | 2011-10-24 |
| Device Manufacturer Date | 2005-12-14 |
| Date Added to Maude | 2012-07-16 |
| 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 BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXC 800 SYNCHRON SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | CEO |
| Date Received | 2011-11-18 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| ID Number | SW VERSION 4.92 |
| Operator | HEALTH PROFESSIONAL |
| 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 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-18 |