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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 040 11 12 001
Date submitted: 1/30/2014
Manufacturer:Radiometer Medical
Device Type:Lactate membrane units
Description:measuring, Lactate, membrane, Analyzers
Medical Device Identifier:The membrane units affected are: All lots of 942-066 When used on:ABL700 Series, and ABL800 Analyzers.
Reason of Field Safety Corrective Action:RADIOMETER recently became aware that some membranes may have enzyme residues on the outer membrane. Upon replacement of the Lactate membrane the enzyme residue may cause an initial negative bias on the reported Lactate result. The bias decreases over the in-use time, and depending on the amount of residue it may take anything between hours and days for the bias to disappear. Worst case the bias upon membrane replacement is -1.5 mmol/L at Lactate levels over 7.0 mmol/L. This is most apparent when comparing results measured before and immediately after membrane replacement.
Remedy Action:1. Wait for the analyzer to complete the startup calibration 2. Perform one quality control measurement (see “Preparation for Quality Control Verification” overleaf) to verify the Lactate performance. In case the result is out of the reduced limits subsequent patient results are questioned to indicate that the bias is present. Please do not report Lactate results over 7.0 mmol/L unless the above is performed upon replacement of the Lactate membrane.

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Swissmedic update action :

The manufacturer has now implemented an end of production line test for lactate membrane units to ensure that lactate membrane units with the issue are no longer released for sale.

With the implementation of the new end of production line test there will be two populations of lactate membrane units, which must be handled differently as indicated below:

For membrane units below Lot 2192: Continue to perform the Quality Control verification of a new Lactate membrane as described previously.

For membrane units of Lot 2192 onwards: It is not necessary to perform the Quality Control verification of a new Lactate membrane. Hence, the procedure given in the Operator’s Manual applies.
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:NCMDR
Source Ref. Number:1E0D4EC48D1CA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20121031_19 ( Radiometer ).pdf