MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-07 for UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER A11812 manufactured by Beckman Coulter, Inc..
[18127919]
The customer contacted beckman coulter, inc. (bec) to report erroneously low total bilirubin (tbil) results for three (3) patient samples generated on their unicel dxc 800 pro synchron chemistry analyzer. The patient results were not reported out of the laboratory. There was no impact to patient treatment. The customer reported that tbil results for the three (3) patient samples were recovering low. Upon repeat analysis on their other unicel dxc 800 pro synchron chemistry analyzer, the tbil results recovered higher. The higher repeated results were reported out of the laboratory. The customer reported that all quality control results for tbil except one were within the laboratory's established ranges at the time of the event. The one outlier quality control result recovered just low and outside of the laboratory's established range. A field service engineer was dispatched to the customer's site. The fse replaced numerous hardware components including: reagent syringe, sample syringe, sample probe and collar wash, a/b valve, reagent syringe t-valve, sample syringe t-valve, and the wash manifold. The performance of the analyzer was then verified by running precision studies. As of (b)(6) 2011, no further contact from the customer has been received for low tbil results. A definitive root cause has not been determined for this event.
Patient Sequence No: 1, Text Type: D, B5
[18452165]
Conclusion: a definitive root cause for the event has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03773 |
| MDR Report Key | 2194291 |
| Report Source | 05,06 |
| Date Received | 2011-08-07 |
| Date of Report | 2011-07-05 |
| Date of Event | 2011-07-05 |
| Date Mfgr Received | 2011-07-05 |
| Device Manufacturer Date | 2006-05-22 |
| Date Added to Maude | 2012-05-01 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CHEMISTRY ANALYZER |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JFM |
| Date Received | 2011-08-07 |
| Catalog Number | A11812 |
| ID Number | SOFTWARE VERSION 4.92 |
| 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 | 2011-08-07 |