||mdprc 095 12 18 001
|Manufacturer:||Siemens Healthcare Diagnostics |
|Device Type:||Dimension Vista Intelligent Lab Systems using a Progard Pretreatment Pack on the onboard Millipore Water Purification Module (WPM)|
|Medical Device Identifier:||Product: Millipore Progard Pretreatment Pack
Siemens Material Number (SMN): 10450564
Lot Numbers: F7MA56608, F7MA50339, F7NA62488,
F8AA93567, F8HA64477, F8AA13966,
F8HA79819, F8BA20457, F8BA35774,
F8DA59251, F8HA91305, F8JA97876,
TGA update codes:
Dimension Vista Lab Systems: 10488217, 10488224, 10444802, 10459469
|Reason of Field Safety Corrective Action:||Siemens Healthcare Diagnostics has identified an issue with Millipore Water Purification Module (WPM) Progard Pretreatment Packs when used with the Dimension Vista Triglyceride assay. An investigation by Siemens identified the potential for patient and quality control (QC) triglyceride results to be erroneously elevated as a result of contamination introduced by the Millipore Progard Pretreatment Pack’s filter fibres.
A positive bias of up to 1.38 mmol/L has been observed.
The potential for falsely elevated results could occur when processing the triglyceride assay immediately following the change of the Progard Pretreatment Pack in the Millipore WPM.
Siemens is not recommending a review of previously generated results.
|Remedy Action:||Actions to be taken by the Customer
If you have received a Progard Pretreatment Pack with a lot number listed in Table 1 and shown in Figures 1 and 2, please follow the steps below upon Progard Pretreatment Pack installation with use of the lots indicated above.
1. Verify your water tank level is 85% or less on the WPM Maintenance screen (press Setup > Supplies > Maintain Water Supply > Maintenance). If your tank level exceeds 85%, use the Advanced->Diagnostics->Prime Pumps routine to lower the tank volume.
2. Replace the Progard filter and perform any other required maintenance as instructed in Section 7 of the Dimension Vista System Operator’s Guide.
3. After the Progard procedure completes, pause the instrument (Operation > Pause), and return to the WPM Maintenance screen (press Setup > Supplies > Maintain Water Supply > Maintenance)
4. Select the “Refill Tank” button. The process will take approximately 40 minutes to complete. An estimated time remaining is shown in the graphical user interface (GUI), and the white Status boxes in the top right indicate the steps of the process.
5. When complete, exit the WPM GUI by pressing “Hide Window.” An instrument reset is automatically performed as part of the process.
6. Process triglyceride QC and ensure all levels are in range. If QC is out of range, do not recalibrate triglyceride; contact your Siemens Technical Support Representative.
If you have received a Progard Pretreatment Pack with a lot number that is not listed above, please continue to use the Progard Pretreatment Pack as instructed in your Dimension Vista System Operator’s Guide.
In addition, please perform the following:
- Review this letter with your Medical Director
- Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
- Return the completed Field Correction Effectiveness Form to Siemens Healthcare Diagnostics as instructed in the last page of this letter.
- If you have received any complaints of illness or adverse events associated with the affected products listed above, immediately contact your local Siemens Customer Care Center or your local technical support provider.
|Athorized Representative/Importer/Distributor:||ABDULREHMAN AL GOSAIBI GTB|
|Report Source:||NCMDR, http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01590-1 |
|Source Ref. Number:||237F64FDC52C8, RC-2018-RN-01590-1|
|SFDA Comments:||SFDA urges all hospitals that have devices subjected to recall, to contact the company.|