MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-09 for UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER A11812 manufactured by Beckman Coulter Inc..
[18417252]
A customer contacted beckman coulter inc. (bec) in regards to obtaining a false low creatinine kinase (ck) result for one (1) patient sample of 3 iu/l (reference range 26 - 276 iu/l) that was generated by the unicel dxc 800 pro synchron chemistry analyzer. The erroneous result was not reported out of the laboratory. The sample was repeated on the same instrument with a result of 95 iu/l (per the printout provided). The sample was also run repeatedly with results of 102, 98, 92, 97, 90, 95, 90, 153 (flier), 90, 99, 100 and 126 (flier) iu/l. It is not known which result was reported. Treatment was not initiated or withheld based upon the false result.
Patient Sequence No: 1, Text Type: D, B5
[18750324]
The customer stated that qc was within lab-established ranges, but only supplied data from after the event (which was within range). No qc data was provided from before the event. A bec field service engineer (fse) was dispatched for this event. The fse replaced the sample probe, syringe, syringe valve, sample mixer paddle and sample mixer bearing. The fse verified instrument performance. A definitive failure mode was not determined; however, multiple parts were replaced and any of which could have affected this assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01594 |
| MDR Report Key | 2646742 |
| Report Source | 05,06 |
| Date Received | 2012-07-09 |
| Date of Report | 2012-06-14 |
| Date of Event | 2012-06-14 |
| Date Mfgr Received | 2012-06-14 |
| Device Manufacturer Date | 2006-11-09 |
| Date Added to Maude | 2012-10-24 |
| 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 INC. |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-07-09 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| Lot Number | N/A |
| ID Number | SW VERSION 4.9 |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-09 |