MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-07 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2414263]
The customer reported an erroneously elevated creatine kinase-mb (ck-mb) result, above the normal reference interval, for one patient, involving unicel dxi 800 access immunoassay system. The ck-mb result did not correlate with the patient's normal cardiac test results at the time of the event. The customer performed system check, and the results were within specifications. Subsequent testing on access 2 immunoassay system produced a lower result, within the normal reference interval. The elevated result was not released out of the laboratory. There was no report of patient injury or change in patient treatment associated with this event. The field service engineer (fse) assessed the unit at the facility.
Patient Sequence No: 1, Text Type: D, B5
[9594722]
The field service engineer (fse) serviced the unit on (b)(6) 2011. The fse noted the unit was operating without issues. The fse verified reagent pipettor alignments and instrument hardware by performing a successful system check and high sensitivity system check; carry over testing, and creatine kinase-mb (ck-mb) precision testing were all within specifications. The unit conformed to the manufacturer's performance specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-00046 |
| MDR Report Key | 2402971 |
| Report Source | 05,06 |
| Date Received | 2012-01-07 |
| Date of Report | 2011-12-08 |
| Date of Event | 2011-12-06 |
| Date Mfgr Received | 2011-12-08 |
| Device Manufacturer Date | 2008-10-23 |
| Date Added to Maude | 2012-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA CA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| 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 | 2012-01-07 |
| Model Number | NA |
| 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 | 2012-01-07 |