Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its iChemVELOCITY Urine Chemistry System [Part Number: All].
As a result of an internal investigation, the manufacturer has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag "S3" and may result in erroneous Specific Gravity (SG) results.
- The S3 value flag is generated when the instrument is unable to measure the Specific Gravity of the sample due to an interference in the sample or a hardware failure.
- The S3 value flag triggers chemistry system flags that are designed to require operator review prior to release of results.
- The iChemVELOCITY Instructions for Use (IFU) incorrectly states that for S3, "The Specific Gravity Result is >1.060. This is a normal condition." The IFU does not state that S3 value flag is generated when the instrument is unable to measure the Specific Gravity of the sample due to an interference in the sample or a hardware failure.
Erroneous Specific Gravity results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment. For affected instruments:
- Specific Gravity results that cannot be measured due to interference or hardware failures are not held for review and are incorrectly released as SG>1.060;
- The operator will not be able to differentiate between results that have been correctly measured and reported as SG>1.060 and those that were unable to be measured, but report as SG>1.060.
According to the manufacturer, for all results held in the Work List or released to the Laboratory Information System (LIS):
- Review results to determine if samples report an SG result of >1.060 or an SG result of S3;
- If the SG result is >1.060 or S3, test samples for SG using an alternate method determined by the laboratory;
- Use the SG results from the alternate test method to change the SG results onboard the instrument, if the Detailed Audit Trail feature is enabled or change the SG results at the LIS;
- If persistent SG results are >1.060 or persistent S3 results are seen, contact the manufacturer.
The FSN serves as a temporary labeling update for this issue. The IFU will be updated. The manufacturer has a software upgrade in progress which is projected to be available starting the first quarter of 2020.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 November 2019