MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-03 for UNICEL? DXL 800 ACCESS? IMMUNOASSAY SYSTEM DXI 800 973100 manufactured by Beckman Coulter Inc..
[1628202]
A customer contacted beckman coulter inc. (bci) regarding a ckmb result above the normal reference range generated by the unicel dxi 800 access immunoassay system for one patient. Upon repeat, the result was within the normal reference range. 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
[8728385]
Sample was li heparin plasma collected in a pst tube and centrifuged for 5 minutes at 6000 rpm. Qc was within the customer's established ranges prior to and after the event. A system check performed on 06/14/2010 met specifications. Per customer, this sample collection tube was only 2/3 of the recommended fill volume. A field service engineer (fse) went on-site and replaced some hardware after which a system check, precision run and qc performed all met specifications. Although a sample issue may have contributed to this event, a clear root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00388 |
| MDR Report Key | 1781561 |
| Report Source | 05 |
| Date Received | 2010-08-03 |
| Date of Report | 2010-07-30 |
| Date of Event | 2010-07-02 |
| Date Mfgr Received | 2010-07-02 |
| Device Manufacturer Date | 2007-08-10 |
| 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 | IN |
| 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 | 2010-08-03 |
| 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 | 2010-08-03 |