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..
[1972148]
A customer reported to beckman coulter inc (bci) that the unicel dxi 800 access immunoassay system generated an erroneously elevated creatinine kinase-mb (ckmb) result above the normal reference range for one (1) patient. The result was reported out of the lab. Repeat testing on an alternate instrument generated a result in the normal reference range that fits the clinical picture of the patient. Patient report was amended. 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
[8983763]
Patient samples were collected in bd lihep serum tubes. Centrifugation information has not been supplied to date. Samples were processed through the automation line. Qc was performing within the customer's established ranges at the time of the event. System check data has not been supplied by customer to date. On (b)(4) 2011, bci field service engineer (fse) was on site and replaced the sample pipettor, peri-pump tubing and aspirate probes. Fse also performed a carryover system check and a high sensitivity system check within instrument specifications to verify hardware after repairs were completed. Although several hardware components were replaced, a definitive root cause has not been determined to date for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01731 |
| MDR Report Key | 2115865 |
| Report Source | 06 |
| Date Received | 2011-06-07 |
| Date of Report | 2011-05-08 |
| Date of Event | 2011-05-07 |
| Date Mfgr Received | 2011-05-08 |
| Device Manufacturer Date | 2006-05-22 |
| 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 |