December 2021 : Initial Reporting FA 21072 : Field Safety Notification on AU/DxC AU Magnesium - IFU update due to lipemic interference for the Magnesium serum application failed to meet the performance specification.
Initial Reporting FA 21072 : Field Safety Notification on AU/DxC AU Magnesium - IFU update due to lipemic interference for the Magnesium serum application failed to meet the performance specification.
Affected Medical Device : AU/DxC AU Magnesium
MDA Reference Number : MDA/FCA/2021-P178
MDA Registration Number : IVDB2268977017
Description :
Beckman Coulter 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. 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.
Local Establishment Contact Detail :
Nur Aishah
REGULATORY AFFAIRS SPECIALIST
O: +03-7772 8256
www.beckmancoulter.com
Beckman Coulter Malaysia
18, Jalan Tandang 51/205a, Pjs 51, 46050 Petaling Jaya, Selangor, Malaysia
Email : [email protected]
