MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-20 for UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER A11812 manufactured by Beckman Coulter Inc..
[19927380]
A customer contacted beckman coulter inc. (bci) in regards to obtaining a false high acetaminophen (actm) result, for one patient sample, of > 300 ug/ml that was generated by the unicel dxc 800 pro synchron chemistry analyzer. The erroneous result was reported to the er. The customer noticed the erroneously high result and repeated the test by diluting the samples (1:1 and 1:2 dilutions), which then generated consistently lower results. The customer confirmed the amended result of <10 ug/ml by testing the straight sample (with no dilutions) on the original instrument and on an alternate instrument. A separate mdr 2050012-2010-01369 was submitted for the malfunction portion of this event. It is unknown if patient treatment was affected from this event.
Patient Sequence No: 1, Text Type: D, B5
[20093972]
Controls were run before the incident and the results were within the established ranges. A field service engineer (fse) was dispatched and ran performance verification tests for carryover studies, which met specifications. This test demonstrated that this is no carryover issue on the instrument. Root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01370 |
| MDR Report Key | 1903971 |
| Report Source | 05 |
| Date Received | 2010-11-20 |
| Date of Report | 2010-11-19 |
| Date of Event | 2010-10-18 |
| Date Mfgr Received | 2010-10-22 |
| Device Manufacturer Date | 2006-04-12 |
| Date Added to Maude | 2012-01-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| Remedial Action | OT |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LDP |
| Date Received | 2010-11-20 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2010-11-20 |