MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-15 for UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM A11812 manufactured by Beckman Coulter, Inc..
[14882822]
The customer reported to beckman coulter, inc (bci) that erroneously low sodium (na) results were obtained on their unicel dxc 800 instrument, the results were reported out of the lab and that there have been similar issues with other dxc 800 instruments. Prior to the event, the ise (ion-selective electrode) sys was calibrated and the qc (quality control) results were within the lab's established range. Around 3 am on (b)(6) 2009, about 25 na results were running low and the erroneous results were discovered later. The ise sys was re-calibrated and qc recovered within range. Samples were repeated and amended reports were issued. The customer did not provide any info regarding pt or sample data. While there is no report of any adverse event or serious injury related to this event, it is unk whether there was any change to pt treatment.
Patient Sequence No: 1, Text Type: D, B5
[15299473]
A bci fse (field svc engineer) was dispatched to the site on (b)(4) 2009 and performed troubleshooting. The fse found that the instrument was functioning properly but still left na electrodes with the customer. A definitive root cause could not be determined. The customer proceeded from this point forward to recalibrate and run controls more frequently. This is 1 of 25 individual medwatch reports which are related to this event. This reportable event was identified during a retrospective review of complaints conducted between 1/1/2008 and 10/23/2010 for add'l reportable events. This is one of twenty-five (25) separate medwatch reports being submitted as this event involves 25 separate pt events that were reported out of the lab.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07287 |
| MDR Report Key | 2393338 |
| Report Source | 05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2009-03-24 |
| Date of Event | 2009-03-22 |
| Date Mfgr Received | 2009-03-24 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2012-07-16 |
| 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 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0863-2010 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM |
| Product Code | CEK |
| Date Received | 2011-11-15 |
| Model Number | NA |
| Catalog Number | A11812 |
| Lot Number | NA |
| ID 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, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |