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(DELETED) Blood Gas Analyzer/GEM Validation Precision CV values and Internal vs External QC
I am trying to validate the new GEM 7000 device but this applies to the GEM 5000 devices as well.
Our Werfen rep ran external QCs for a precision study with external controls and had an observed CV of 14.3%.
Ideally shouldn't the CV be <5% ?
Should it be based on manufacturer's insert?
What is everyone's policy?
Based on the manufacturer's precision study, didn't they also fail?
Calling Werfen technical support is not very he...
Our Werfen rep ran external QCs for a precision study with external controls and had an observed CV of 14.3%.
Ideally shouldn't the CV be <5% ?
Should it be based on manufacturer's insert?
What is everyone's policy?
Based on the manufacturer's precision study, didn't they also fail?
Calling Werfen technical support is not very he...
Cory Zawikowski posted a reply on Re: Gem 5000 cartridge issues
Tuesday, Jan 6, 2026 at 8:05 AM
Said: I have 18 GEMs at my facility and have had a couple of paks kick off for similar reasons over this past weekend as well. I assign blame for PCS solution errors on the shipping process, and I had one pO2 failure and then another one that...
Carrie Leipzig posted a reply on Re: Does a PharmD qualify you as a Technical Co...
Tuesday, Jan 6, 2026 at 8:01 AM
Said: Agree with JoAnn, a credit evaluation must be completed to determine if they qualify.
Jessica Lang posted a new Topic
Tuesday, Jan 6, 2026 at 7:41 AM
Gem 5000 cartridge issues
Good morning. We have had 3 bad gem cartridges within a one week period and I was wondering if anyone else was having any issues. 2 of them leaked PCS solution in their original packaging and one was an out of the box pO2 failure which we've had before. Just a little concerned since we only have 2 instruments and this one is in our Cath Lab.
Cindy Sorensen posted a reply on Re: GH 100 and Telcor
Monday, Jan 5, 2026 at 3:41 PM
Said: Erika,Sorry I missed your call, could you try again? I do have all the necessary settings in QML.
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