Medical references were reviewed by dma to attempt a determination on whether patient's pancreatic lymphoma and subsequent chemotherapy could have caused interference with dma's arsenazo iii based assay. Literature references wer inconclusive regarding the effect on calcium assays caused by the patient's medication. The literature review did indicate that pancreatic cancers can cause a patient to have elevated serum calcium levels. Dma attempted to contact the patient's doctor for further information as part of the review process, however the doctor was unresponsive in returning calls placed by dma. As of 11/18/97, no further information has been received by dma from the reporting facility. The decision to file an mdr on this report was based on the definition of "serious injury" which includes the term "medical intervention". While the patient bf did not receive treatment in this incident, the act of being admitted to a hospital has been deemed to within the scope of "medical interventiono". No other mdr's have received by dma on this product as of 11/18/97. 1. Product labeling reviewed - product labeling for dma calcium plus includes section on interfering substances which lists substances which have the potential to interfere with this assay. Included in the interfering substances section is reference to the fact that a literature source is available which contains information on drug interferences. 2. Literature review - a literature review was conducted by dma regulatory to determine if any patient medications reported could cause elevated serum calcium results. (references below) results of this review provided no clear cut relationship between patient medications and elevated serum calcium results obtained by the reporting facility. 3. Product performance testing - an identical unit of dma #1265 calcium plus, from the same lot number reported in this incident was tested at dma. Product performance was within specifications.

While undergoing routine medical testing, a patient was identified as having an elevated serum calcium level. This serum calcium level was determined during an in-control assay utilizing data medical associates inc. (dma) catalog #1265, calcium plus reagent. All other patient samples tested at this time were within the normal range. On the basis of test result, her doctor admitted her to a hospital for the purpose of lowering the serum calcium level. Prior to starting treatment, a second assay was performed on a fresh sample of serum utilizing a calcium reagent of another methodology. This second assay found a normal serum calcuim level to be present. Due to these test results, a third assay of another methodology was performed. The two assays performed after she was admitted to the hospital found that the patient's serum calcium level was normal. The medical technologist reporting this incident to dma conveyed in a phone converstation that after two tests determined she had a normal serum calcium level, she was released from the hospital without receiving treatment.