MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-09-23 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2237466]
An international beckman coulter rep reported erroneous cytomegalovirus (cmv) g antibody for pts' and quality control results involving unicel dxi 800 access immunoassay system. When the erroneous results were transmitted to an alternate dxc system screen, results were normal. The international rep rebooted the system, but it did not resolve the issue. It is unk if pts were impacted. There ahs been no report of pt injury or change in pt treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9419133]
There is no indication service was dispatched. This reportable event was identified during a retrospective review of product complaints conducted from jan 1, 2008 through oct 23, 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-03977 |
| MDR Report Key | 2274008 |
| Report Source | 01,07 |
| Date Received | 2011-09-23 |
| Date of Report | 2009-04-17 |
| Date of Event | 2009-04-09 |
| Date Mfgr Received | 2009-04-17 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2011-11-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 1000 LAKE HAZELTINE DR. |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-05/20/2009-005C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Product Code | OMI |
| Date Received | 2011-09-23 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID 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 DR. CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-23 |