MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-07 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY ANALYZER 973100 manufactured by Beckman Coulter Inc..
[2009674]
A customer reported to beckman coulter inc (bci) that the unicel dxi 800 access immunoassay system generated a false positive creatinine kinase-mb (ckmb) result for one (1) patient. The result was reported out of the lab. Repeat testing on the same instrument generated lower results. 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
[9130001]
Customer did not provide qc, calibration or system check data. Customer noted that fibrin was in the sample that yielded the erroneous result. On (b)(4) 2011, bci field service engineer (fse) was on site and found the dispense probe plate out of alignment. Fse corrected alignment and verified system performance to published specifications. Although alignment was adjusted, root cause is associated with user error (pre-analytical sample handling).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01729 |
| MDR Report Key | 2115863 |
| Report Source | 06 |
| Date Received | 2011-06-07 |
| Date of Report | 2011-05-06 |
| Date of Event | 2011-05-02 |
| Date Mfgr Received | 2011-05-06 |
| Device Manufacturer Date | 2005-09-02 |
| Date Added to Maude | 2011-09-21 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXI 800 ACCESS? IMMUNOASSAY ANALYZER |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2011-06-07 |
| Model Number | DXI 800 |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-06-07 |