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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 003 11 18 000
Date submitted: 11/5/2018
Manufacturer:Siemens Healthcare Diagnostics
Device Type:Dimension Vista System utilising Lactate Dehydrogenase (LDI) Flex reagent cartridge.
Description:Clinical chemistry enzyme IVDs
Medical Device Identifier:Catalogue Number: K2054

Siemens Material Number (SMN): 10464323
Reason of Field Safety Corrective Action:Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted.

Incomplete removal of residual lactate dehydrogenase, a component of the LA reagent, has been identified as the cause of the potentially elevated result.
Remedy Action:Siemens is working to provide an updated software version which will resolve this issue. Until the updated software version is installed, Siemens is advising users to take the following actions: · If both LDI and LA assays are not being used, no action is required. · If both LDI and LA assays are being used on the Dimension Vista System: o Dimension Vista 1500 System: Separate LDI and LA assays onto different servers by configuring LDI onto Server 2. LA can only be processed on Server 1. o Dimension Vista 500 System: Laboratories with an additional instrument must process LDI and LA assays on separate instruments. If the laboratory only has one Dimension Vista 500 System instrument, configure LDI testing to run in duplicate. If the LDI results are discordant with each other, contact the local Siemens Technical Support Representative for further guidance. Alternatively, users can choose to process either lactate dehydrogenase or lactic acid using an alternate methodology.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:B88212EB2C263
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics Inc..pdf