MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-05 for UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2786260]
The customer reported that erratic creatine kinase-mb isoenzyme (ck-mb) results, above and within the normal reference range, were generated on a unicel dxl800 access immunoassay system for multiple patient samples. Beckman coulter inc. Assessment of customer supplied data indicated the involvement of three patients' ckmb results. One patient's erratic ckmb results crossed the upper reference limit of the assay while repeat testing on the same instrument and an alternate instrument produced lower results within the normal range of the assay. The second patient's ckmb results were all above the normal range of the assay but they were not reproducible within the labeled assay precision claims. The third patient's results were all within the normal reference range of the assay however were not reproducible within the labeled assay precision claims. All of these patient's ckmb results were accompanied by an instrument generated clx flag. The customer provided additional patient ckmb data however these patient ckmb results were reproducible and were within the normal reference range of the assay and hence were not regarded as erroneous and were excluded from this report. Other assay results were also provided for other patient samples; however these were not regarded as erroneous by the customer. The suspect ckmb results were not reported outside of the laboratory and hence there was no death, serious injury or modification to patient treatment associated or attributed to this event. The samples were lithium heparin samples without gel separators. It is unknown whether the samples were full draws or possessed evidence of fibrin. The samples were centrifuged at room temperature prior to testing. Beckman coulter inc. Assessment of customer supplied instrument/assay performance data indicated that assay instrument quality control (qc) was performing within the customer's established limits on the morning of the event. A system check performed after the event failed to pass within instrument specifications and failing calibration curves also occurred after the event. The reagent and calibrator lots associated with this event were 123056 and 119344 respectively.
Patient Sequence No: 1, Text Type: D, B5
[9824971]
Service was dispatched to the site for this event. The field service engineer (fse) reported that system checks were failing when the fse performed the service assay. The fse also reported that cardiac troponin calibrations would not pass. The fse was able to perform a passing system check and assay calibrations after they assessed the instrument the cause of this event could not be determined based on the supplied information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01424 |
| MDR Report Key | 2598163 |
| Report Source | 05,06 |
| Date Received | 2012-06-05 |
| Date of Report | 2012-05-13 |
| Date of Event | 2012-05-13 |
| Date Mfgr Received | 2012-05-13 |
| Device Manufacturer Date | 2009-01-27 |
| Date Added to Maude | 2012-09-28 |
| 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 DXL800 ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-06-05 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | SOFTWARE 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 BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-05 |