MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-18 for UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM A11810 manufactured by Beckman Coulter, Inc..
[2270371]
The customer contacted beckman coulter, inc (bci) to report low test results for electrolytes and calcium were obtained for 5 patient samples when using the unicel dxc 600 synchron clinical system. Test results for one of the 5 patient samples were reported out of the laboratory. While there is no report or adverse event or serious injury related to this event, it is unknown whether there was a change to patient management. This issue was initially reported as mdr 2050012-2010-00217. Upon retrospective review of the mdr, it was determined that an additional mdr was required to report the test results for potassium and chloride for the patient that was reported out of the laboratory.
Patient Sequence No: 1, Text Type: D, B5
[9565459]
Calibration was performed every 24 hours or as indicated by quality control (qc). Qc was run every 8 hours. The qc results shifted greater than 2 sd (standard deviations) for calcium and potassium. Qc was okay after customer recalibrated the instrument. The customer noticed for some time that qc results are shifted after the instrument is in standby for an extended time. The customer routinely performs twice weekly maintenance procedure using sodium hypochlorite. The customer stated there are some issues with the laboratory temperature control. Fse (field service engineer) decontaminated the ise (ion-selective electrode) system and replaced the carbon bridge and ratio pump seals. Fse also replaced sodium electrodes, potassium, calcium and chloride electrode tips. Root cause was not determined. This reportable event was identified during a retrospective review conducted between january 1, 2008 and october 23, 2010 of complaints for additional reportable events. This event was initially reported as mdr 2050012-2010-00217. During the retrospective review it was determined that another mdr was required to report the test results for potassium and chloride for the patient that was reported out of the laboratory. This mdr reports that event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07727 |
| MDR Report Key | 2349864 |
| Report Source | 05,06 |
| Date Received | 2011-11-18 |
| Date of Report | 2010-04-01 |
| Date of Event | 2010-04-01 |
| Date Mfgr Received | 2010-04-01 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-07-17 |
| 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 600 SYNCHRON CLINICAL SYSTEM |
| Generic Name | NONE |
| Product Code | CEK |
| Date Received | 2011-11-18 |
| Model Number | NA |
| Catalog Number | A11810 |
| Lot Number | NA |
| ID Number | NA |
| 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 BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-18 |