MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-05 for UNICEL DXI? 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter.
[3641051]
The customer reported obtaining an erroneously low creatinine kinase (access ck-mb) result for one (1) female patient, above the normal reference range of the assay, from the unicel dxi 800 access immunoassay system. The customer reported the result out of the laboratory; however, it is unknown if there was any change or affect to patient treatment in connection with this event. Subsequent repeat of the sample on an alternate dxi 800 analyzer recovered a higher ck-mb result, above the normal reference range of the assay again, which better matched the expected value for the patient. All system parameters, including calibrations and quality control (qc) results, performed within assay/instrument specifications prior to the event. Qc results following the event recovered low and out of the laboratory's established ranges. The customer reported of having low qc recovery on multiple assays on the days leading up to the event, but the customer did not supply the qc data for review.
Patient Sequence No: 1, Text Type: D, B5
[10983665]
A beckman coulter field service engineer (fse) was dispatched to the customer's site. The fse discovered that the aspiration of aspirate probe #3 was slow in comparison to the other aspirate probes. The fse proceeded to replace all peri pump tubings to resolve the issue and verified repair per established procedures. Failure mode of the event is likely a hardware malfunction; the fse determined that the aspiration of aspirate probe #3 was slow and proceeded to replace all peri pump tubings to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00680 |
| MDR Report Key | 3263053 |
| Report Source | 05,06 |
| Date Received | 2013-08-05 |
| Date of Report | 2013-07-15 |
| Date of Event | 2013-07-15 |
| Date Mfgr Received | 2013-07-15 |
| Device Manufacturer Date | 2008-07-14 |
| Date Added to Maude | 2013-10-30 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 | 2013-08-05 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | SW 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-05 |