MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-10 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2904932]
The customer reported an erroneous creatine kinase-mb (ck-mb) result, above the normal reference range, for one patient, involving the unicel dxi 800 access immunoassay system. Subsequent analysis of the patient sample, on the original and an alternate instrument recovered lower results, above the normal reference range. The erroneous result was not released out of the laboratory. There was no patient impact associated with this event. Beckman coulter field service engineer (fse) was dispatched to evaluate the instrument.
Patient Sequence No: 1, Text Type: D, B5
[10331027]
The field service engineer (fse) performed verification testing of instrument hardware and completed creatine kinase-mb (ck-mb) precision study with acceptable results. The fse noted high sensitivity system check results failed. The fse inspected the instrument for causes of the high sensitivity system check failure and did not note any failures or malfunctions. The fse replaced the mixer belt, idler pulley, and the aspirate probes. The fse performed modifications and replaced gripper/spinner and peristaltic pump cassettes and tubing. The fse performed all analytical module alignments. A passing system check and high sensitivity system check were completed to verify instrument performance. Service activity performed was verified to meet the specified requirements per established procedures. The unit conformed to the manufacturer's published performance specifications and was returned to normal operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01977 |
| MDR Report Key | 2864111 |
| Report Source | 05,06 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-09 |
| Date of Event | 2012-11-09 |
| Date Mfgr Received | 2012-11-09 |
| Device Manufacturer Date | 2005-09-06 |
| Date Added to Maude | 2013-03-11 |
| 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 |
| 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 MN 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 | JLB |
| Date Received | 2012-12-10 |
| Model Number | NA |
| 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 | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-10 |