MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-27 for UNICEL? DXC 600I SYNCHRON? ACCESS CLINICAL SYSTEM A25640 manufactured by Beckman Coulter.
[3129062]
A customer reported to beckman coulter that unicel dxc 600i synchron access clinical system generated erratic ck-mb results that were not reproducible. The initial result was within the normal reference range, but upon repeat an elevated ck-mb result outside the published precision claim was obtained. The customer performed repeat testing a few more times on the same and on an alternate instrument, and reported out the result that was considered the most accurate for the patient. The customer believed no erroneous results were released out of the laboratory. There was no report of death, injury, or change to patient treatment associated to this event. Beckman coulter field service engineer (fse) was dispatched to the customer site to verify hardware performance in response to this event. The fse found that the incubator belt was out of alignment and performed the incubator belt alignment procedure. The fse noted that the incubator belt misalignment may have caused splashing within the reaction vessel, incomplete washing of the unbound analyte, and therefore erratic recovery of the ck-mb assay.
Patient Sequence No: 1, Text Type: D, B5
[10508276]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00132 |
| MDR Report Key | 2979606 |
| Report Source | 05,06 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-01-31 |
| Date of Event | 2013-01-30 |
| Date Mfgr Received | 2013-01-31 |
| Device Manufacturer Date | 2011-05-23 |
| Date Added to Maude | 2013-04-03 |
| 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 | 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600I SYNCHRON? ACCESS CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-02-27 |
| Model Number | DXC 600I |
| Catalog Number | A25640 |
| 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-27 |