MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-27 for UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER N/A A11812 manufactured by Beckman Coulter Inc.
[1508304]
Customer contacted beckman coulter inc. (bci) in regards to several erroneous low phosphorous (phos) patient results, which were generated by unicel dxc 800 pro chemistry analyzer. One patient was treated based on the erroneous results, just before the amended result was called in. The results were reported out of the laboratory. An amended reports were issued.
Patient Sequence No: 1, Text Type: D, B5
[8626871]
The samples were serum. Calibration appears acceptable before the event. Qc chart from the previous week resulted in one low and two high phosm fliers. A field service engineer (fse) replaced the phosm module and associated tubing. A clear root cause can not be identified for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-00298 |
| MDR Report Key | 1701448 |
| Report Source | 05 |
| Date Received | 2010-05-27 |
| Date of Report | 2010-05-27 |
| Date of Event | 2010-05-04 |
| Date Mfgr Received | 2010-05-04 |
| Device Manufacturer Date | 2009-01-22 |
| Date Added to Maude | 2010-05-28 |
| 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 BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613436 |
| Manufacturer G1 | COULTER BECKMAN INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEO |
| Date Received | 2010-05-27 |
| Model Number | N/A |
| Catalog Number | A11812 |
| 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 | 2010-05-27 |