MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-22 for UNICEL DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[15761824]
A customer contacted beckman coulter, inc. (bec) to report obtaining an erroneously elevated creatine kinase-mb (ckmb) result above the normal reference range of the assay for one (1) patient during the period from (b)(6) 2011. The results were generated on a unicel dxi 800 access immunoassay system, used in conjunction with access ckmb reagent (lot 023761) and access ckmb calibrators (lot 022298). This report is one of two and represents the erroneous result generated on (b)(6) 2011. The initial ckmb result was reported out of the laboratory. Repeat testing of the patient sample on the same instrument generated a lower result that was within the normal reference range of the assay. The initial report was amended with this result. 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
[15870169]
Patient samples were collected in plasma separator tubes and centrifuged for 6 minutes at 5000 rpm or processed through the automation line. Quality control was performing within the customer's established limits on the date of the event. Per the field service engineer (fse)'s request, the customer performed a system check on (b)(6) 2011. The check failed to pass within instrument specifications. The fse completed a preventive maintenance (pm) upon arrival at the site. The fse then performed a high sensitivity system check and carry over testing. All passed within instrument specifications. Mdrs associated with this event: 2122870-2011-03998, 2122870-2011-04011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-03998 |
| MDR Report Key | 2260814 |
| Report Source | 05,06 |
| Date Received | 2011-09-22 |
| Date of Report | 2011-08-25 |
| Date of Event | 2011-08-23 |
| Date Mfgr Received | 2011-08-25 |
| Device Manufacturer Date | 2007-10-12 |
| Date Added to Maude | 2011-10-05 |
| 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 | 3 |
| 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 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 SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JHS |
| Date Received | 2011-09-22 |
| Model Number | DXI 800 |
| Catalog Number | 973100 |
| Lot 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 | 2011-09-22 |