MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-28 for UNICEL? DXC 600I SYNCHRON? ACCESS? 2 CLINICAL SYSTEM A25640 manufactured by Beckman Coulter Inc..
[1566442]
A customer contacted beckman coulter inc. , (bci) and reported that when running ckmb qc and patients samples on the unicel dxc 600i synchron access 2 clinical system the instrument generated ind/no value flags on all samples. The customer did not supply the exact number of patients' samples affected. The results were not reported out of the lab. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
[8733187]
No sample collection, qc or system check data was supplied to date. While troubleshooting with customer technical specialist (cts), the customer was asked to unload the in-use ckmb reagent pack to inspect it for damage. The customer stated there was no pack present in the slot indicated. Product labeling instructs customers how to load reagent packs. Reagent packs must be properly loaded to run an assay. Service was not dispatched as pack mis-loading was found to be the root cause for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00379 |
| MDR Report Key | 1772443 |
| Report Source | 05 |
| Date Received | 2010-07-28 |
| Date of Report | 2010-07-27 |
| Date of Event | 2010-07-03 |
| Date Mfgr Received | 2010-07-03 |
| Device Manufacturer Date | 2009-01-26 |
| Date Added to Maude | 2010-08-11 |
| 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 BLVD. |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600I SYNCHRON? ACCESS? 2 CLINICAL SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2010-07-28 |
| Model Number | NA |
| Catalog Number | A25640 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-28 |