MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-08 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter Inc..
[1344441]
A customer contacted beckman coulter inc. , (bci) regarding elevated ckmb results generated by the unicel dxi 800 access immunoassay system for one patient. The original sample was re-tested on a different instrument and lower results were obtained. The results were not reported out of the lab. No reports of death, injury, or change to patient treatment have been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[8634459]
The specimen was lithium heparin collected in a pst tube and centrifuged at 6,000 rpm for 5 minutes. Qc was within the customer's established ranges prior to and after the event. A field service engineer (fse) was dispatched: the fse rebuilt the precision pumps as a preventive measure. No hardware issues were noted that would contributed to the event. The fse performed diagnostic testing and results met specifications. A clear root cause has not been determined to date for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00307 |
| MDR Report Key | 1749974 |
| Report Source | 05 |
| Date Received | 2010-07-08 |
| Date of Report | 2010-07-08 |
| Date of Event | 2010-06-12 |
| Date Mfgr Received | 2010-06-13 |
| Device Manufacturer Date | 2007-08-10 |
| Date Added to Maude | 2010-08-10 |
| 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 BLVD. |
| 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 | IN |
| Previous Use Code | 3 |
| 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 | 2010-07-08 |
| Model Number | NA |
| Catalog Number | 973100 |
| 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 | 2010-07-08 |