MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-01-05 for UNICEL? DXL 800 ACCESS? IMMUNOASSAY SYSTEM DXI 800 973100 manufactured by Beckman Coulter Inc..
[1310843]
Customer contacted beckman coulter inc. (bci) regarding serum total t4 (tt4) results generated by the unicel dxi 800 access immunoassay system that did not correlate with a plasma sample from the same patient. The serum sample gave a result of 7. 40 ug/dl and 2 repeat results of 7. 96 ug/dl. Another serum sample from this patient gave a result of 8. 07 ug/dl and a repeat result of 7. 62 ug/dl. A plasma sample from this patient was then tested and gave a result of 2. 74 ug/dl and 2 repeat results of 1. 00 and 1. 98 ug/dl. Another plasma sample gave results of 3. 73 ug/dl and 2. 73 ug/dl upon testing. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed to or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
[8319158]
Samples are collected in either plastic lihep tubes with a gel separator or serum tubes and centrifuged for six minutes at 3000 rpm. Qc was within the customer's established ranges prior to and after the event. System check performed initially failed but passed upon repeat. There is no indication that service was dispatched for this event. A clear root cause for this event has not been determined to date. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00008 |
| MDR Report Key | 1570131 |
| Report Source | 05 |
| Date Received | 2010-01-05 |
| Date of Report | 2010-01-05 |
| Date of Event | 2009-12-13 |
| Date Mfgr Received | 2009-12-16 |
| Device Manufacturer Date | 2007-03-14 |
| Date Added to Maude | 2010-03-10 |
| 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 CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 100 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXL 800 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | KLI |
| Date Received | 2010-01-05 |
| Model Number | DXI 800 |
| Catalog Number | 973100 |
| 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 | 100 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-05 |