Medical device manufacturer, Beckman Coulter, issued a medical device safety alert concerning its AU/DxC AU Magnesium [Reference: OSR6189; All Lots].

Internal interference testing in accordance with current CLSI guideline EP07 version 3 was completed as part of the In Vitro Diagnostic Regulation remediation project by the manufacturer. This testing was completed at lower and higher levels of analyte than specified in previous versions of the guideline. The manufacturer has determined that the lipemic interference for the magnesium serum application failed to meet the performance specification as defined in the IFU as follows:

• Interference less than 10% up to 500 mg/dL Intralipid

According to the manufacturer, a clinically significant interference due to intralipid concentration at 500mg/dL may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The manufacturer did not observe any clinically significant effect on high magnesium patient sample recovery.

The manufacturer is instructing affected users to take the following actions:

• Where LIH influence check settings are enabled, affected users must update the lipemia influence check settings on their AU/DxC AU analyzers.
• If LIH influence check settings are not enabled, affected users should review the new interference information in the IFU and assess whether changes are required to the reporting of magnesium results in the laboratory information system based on LIH flagging.

The manufacturer will update the following statement in the Magnesium IFU (BLOSR6189) Interference section:

• Lipemia: Interference less than 10% or 0.12mmol/L up to 200 mg/dL Intralipid

The manufacturer will also reduce the lipemia influence check setting of the Magnesium setting sheet (BSOSR6189) from +++++ to ++.

According to the local supplier, the affected devices are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 08 Dec 2021