MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-12 for UNICEL? DXC 600 PRO SYNCHRON? CHEMISTRY ANALYZER A11810 manufactured by Beckman Coulter, Inc..
[1833121]
A customer contacted beckman coulter inc. (bci) in regards to high alcohol (etoh) results generated by unicel? Dxc 600 pro synchron? Chemistry analyzer for a liver transplant patient. The customer ran 2 different sample tubes for this patient, and both resulted in 7. 7 mg/dl. The results were reported to the attending physicians, who questioned the results. The event delayed liver transplant, and the patient was put back on the transplant list.
Patient Sequence No: 1, Text Type: D, B5
[8715385]
Qc or calibration was not in question. No alternative method or confirmation was performed on these samples. No service was requested or initiated. A root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-00870 |
| MDR Report Key | 1866106 |
| Report Source | 05 |
| Date Received | 2010-10-12 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-09-14 |
| Date Mfgr Received | 2010-09-14 |
| Device Manufacturer Date | 2006-11-28 |
| Date Added to Maude | 2010-10-13 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600 PRO SYNCHRON? CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMSTRY ANALYZER |
| Product Code | DIC |
| Date Received | 2010-10-12 |
| Model Number | DXC 600 PRO |
| Catalog Number | A11810 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-12 |