MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-20 for UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER A11812 manufactured by Beckman Coulter, Inc..
[2195978]
The customer contacted beckman coulter, inc. (bec) to report erroneous results for phosphorus (phosm) and sodium (na) for one (1) patient sample generated on their unicel dxc 800 pro synchron chemistry analyzer. The erroneous results were reported outside of the laboratory. Based on the erroneous phosm result, the patient was administered treatment for low phosphorus. The customer reported it was unknown if the patient was affected by the treatment. The customer reported that quality control (qc) results were recovering within the laboratory's established ranges at the time of the event. The customer reassayed the patient sample on another analyzer and obtained higher results. An amended report was generated and reported outside of the laboratory.
Patient Sequence No: 1, Text Type: D, B5
[9394153]
A field service engineer (fse) was dispatched to the customer's site. The fse observed that the modular chemistry sample syringe was not moving up and down and that there was no error message flag on the monitor or in the event log. The fse observed that the coupler between the modular chemistry sample drive motor and the syringe was loose. This caused the motor to turn without driving the syringe. The fse reset and tightened the coupler. The fse performed calibrations, ran quality controls, and a precision analysis. All results recovered within established ranges. The event described in this medwatch report is related to four other events which occurred at the time of this event. The related medwatch report numbers are: 2050012-2011-04041, 2050012-2011-04079, 2050012-2011-04080, 2050012-2011-04082.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-04081 |
| MDR Report Key | 2255301 |
| Report Source | 05,06 |
| Date Received | 2011-09-20 |
| Date of Report | 2011-07-14 |
| Date of Event | 2011-07-14 |
| Date Mfgr Received | 2011-07-14 |
| Device Manufacturer Date | 2007-12-14 |
| Date Added to Maude | 2011-09-20 |
| 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. 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 CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | CEO |
| Date Received | 2011-09-20 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| ID Number | SOFTWARE VERSION 4.92.00 |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-20 |