Featured LabNet Report of Interest
MedSun: Newsletter #48, May 2010

Your reports of actual adverse events, and more importantly, reports of 'potential for harm', 'near miss', and 'close call' medical device related safety concerns are of special interest to FDA, MedSun and LabNet. The following event reported by a MedSun LabNet facility resulted in manufacturer action:

Type of Device: Chemistry Analyzer
Device Manufacturer’s Name: Beckman Coulter, Inc.
Date of this report: March 16, 2010
Model: DXC 600I
Product Name: UniCel DxC Synchron Clinical Systems

Reported Event: Incorrect sodium result released. A sodium result was reported as high at 151. The MD called the lab questioning the result. A repeat specimen obtained and was within the normal limits of 138. It was then discovered that there was an issue with the instrument and the initial result was corrected. There were a total of seven patients that had incorrect sodium results posted and then corrected that same day. The other six were outpatients that were corrected within 14 minutes to 3 hours and no patient care decisions were made on any of those patients. None of the patients had labs repeated. All the initial results that were high (149-153) were corrected with all results being within normal limits (136-141). The difference between the initial and corrected results ranged from 10 to 16 points. The lab had been complying with all recommendations and requirements related to maintenance of the electrode module that had been released over the past several months by Beckman and the FDA.

Related Recall: Please see the following Class 1 recall for this model (and others) of the Beckman Coulter UniCel DxC Synchron Clinical Systems. The reason for recall is excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results. To read the FDA recall notice, see link provided under Addition Information below.

Additional Information:

Medical Device Recall. OneTouch Beckman Coulter UniCel DxC Synchron Clinical Systems Class I Recall. March 4, 2010.

MedSun Report. March 16, 2010. Online Available:

FDA Patient Safety News (video) - Recall of UniCel DxC Clinical Analyzers. May 2010.

MedSun Newsletters are available at www.fda.gov/cdrh/medsun