MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-06 for UNICEL? DXL 800 ACCESS? IMMUNOASSAY SYSTEM DXI 800 973100 manufactured by Beckman Coulter Inc..
[1355922]
A customer contacted beckman coulter inc. (bci) regarding elevated ckmb results generated by the unicel dxi 800 access immunoassay system for one patient. Subsequent testing produced results within the normal reference range. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
[8794199]
Qc was within the customer's established ranges prior to and after the event. A routine system check was performed on (b)(4) 2010 which passed within instrument specifications. A field service engineer (fse) went on-site and replaced some hardware and serviced the instrument. Although hardware issues were addressed,a clear root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00414 |
| MDR Report Key | 1788277 |
| Report Source | 05 |
| Date Received | 2010-08-06 |
| Date of Report | 2010-08-06 |
| Date of Event | 2010-07-11 |
| Date Mfgr Received | 2010-07-14 |
| Device Manufacturer Date | 2008-10-23 |
| Date Added to Maude | 2010-08-11 |
| 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 | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | JHS |
| Date Received | 2010-08-06 |
| 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 | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-06 |