MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-20 for UNICEL? DXI 800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter Inc..
[16097510]
The samples were collected in either bd lihep plasma tubes or serum tubes with a gel separator. Per the customer supplied qc charts, all three levels of ckmb and progesterone qc were within the customer's established ranges prior to and on the day of the event. A field service engineer (fse) was dispatched on (b)(6) 2010 for this event. The fse discovered that the aspirate probes were not aspirating properly. The fse replaced the peri-pump tubing and the aspirate probes. Fse performed a routine system check which passed within instrument specifications. A definitive root cause has not been determined to date for this event with the data provided.
Patient Sequence No: 1, Text Type: N, H10
[16257486]
A customer contacted beckman coulter inc. (bci) in regards to obtaining erroneously elevated creatinine kinase - mb and progesterone results for an unknown number of patients generated by the unicel dxi 800 access immunoassay system. The erroneous results were reported outside the laboratory; however, subsequent testing was performed on an alternate instrument producing lower results in a different clinical category and corrected reports were issued. 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
| Report Number | 2122870-2010-00791 |
| MDR Report Key | 1903950 |
| Report Source | 05 |
| Date Received | 2010-11-20 |
| Date of Report | 2010-11-19 |
| Date of Event | 2010-10-21 |
| Date Mfgr Received | 2010-10-21 |
| Device Manufacturer Date | 2009-03-19 |
| Date Added to Maude | 2011-09-14 |
| 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 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2010-11-20 |
| Model Number | DXI 800 |
| Catalog Number | 973100 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-11-20 |