MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-19 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2796331]
Customer reported to beckman coulter, inc. (bec) that the unicel dxi 800 access immunoassay system (dxi 800) generated two erroneous ckmb results on two separate patient samples. Customer reported that the erroneous results were not reported out of the laboratory. There was no report of any adverse event or injury requiring medical intervention or patient treatment. Customer reported that access ckmb reagent, lot 222907, and access ckmbi calibrators, lot 123586, were used in conjunction with the dxi 800 system. Bec field service engineer (fse) replaced the sample probe proactively. The fse performed verification testing which passed within instrument specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2012-01707 |
| MDR Report Key | 2705213 |
| Report Source | 05,06 |
| Date Received | 2012-08-19 |
| Date of Report | 2012-07-25 |
| Date of Event | 2012-07-25 |
| Date Mfgr Received | 2012-07-25 |
| Device Manufacturer Date | 2011-07-23 |
| Date Added to Maude | 2012-12-05 |
| 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. DUNG NGUYEN |
| 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 |
| 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 | 2012-08-19 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | S W VERSION 4.4 |
| 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 BOULEVARD BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-19 |