4 Hemochron devices display incorrect date

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We have RALS for data management and noticed that the time stamping in RALS was wrong for several patient results. The result and transfer time were a future date from the download time (result time should always be the earliest)! We isolated the devices, and had 4 Hemochrons with future dates. We've spoken to RALS and to Werfen and neither one is claiming it as their problem. The Hemochrons are located in different areas in our hospitals, had different future dates, and none share the same digiport to download. Has anyone had a similar situation?

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i should also note that we have lock out in RALS for date and time and a PIN for pour super users to change the time for Daylight Savings Time, so it would be unusual for an operator to change a date in one device let alone 4....

We were just speaking about this on our technical team meeting.  We have had occasions, years ago, that our Sig Elites would lose their time and date and when trying to find the data the date/time was years into the future.  Well it is now the future and these results might be showing up in the result review.  If you are using an older signature elite and that instrument has ever lost its time and date, this might be what is happening.

I use RALS as well. Do you also use Configuration Manager for your Hemochrons?  Ran into this same scenario last week with one of my Gem Hemochron 100s. In my situation either pulling the device back on configuration manager to check a setting either caused the date and time stamp to go back to default which is Los Angelos time and I may have missed this when sending new data to the device or it reverted on its own for reasons unknown. Downloaded logs off the Hemochron and sent to Werfen for review.  Without a Supervisor password you cannot change the date/time stamp. 

We noticed the same thing last week.  The meters must have had a date in the future in January 2024. I agree with what everyone else has stated.  When we looked up the patients they were from the summer and had been discharged.

Did anyone report this to FDA Watchlist by chance? Our management has identified this as a possible next step especially since neither vendor claims the issue is theirs.

We had the same issue.   We had a hemochron that was "stuck" in transferring results back in  August.   In order to reset it, we had to let the battery drain completely.    When the instrument was turned back on after the battery was completely drained the date went to 1/1/2024.   We did not notice this for a few days and had results and EQC that were dated for January 2024 but were actually run in August.     When January 2024 rolled around we had those results from  August showing up on our reviews on our middleware.   

Hi Stacy, which model of Hemochron are using? 

If you are using the Signature Elite, did you send any of those instruments away for service?

We are using Sig Elite and I know for a fact that we recently sent two of these analyzers back in for service (within the last 6 months to year). 

This happened to one of the Cath labs that I managed when we were using the SIgnature Elites (we now have the Hemochron 100s which can be configured  to take the network date and time). IF memory serves me, the Sig Elites did not pick up the date and time from the network as we always had to manually update the time for Daylight Savings time changes. Is that still the case with the version of Sig Elites that you have?

Yes they have to manually update the time for DST and they have to go in an enter in a supervisor pin (set up through RALS). In this case it was set to a date 6 weeks in the future. 

That is what happened to my Cath Lab and that is when I learned that whenever you have instruments return from service you have to check the date and time in the instrument especially if Werfen had to replace a motherboard.
Now with the Hemochron 100s, when they come back from service the default time zone in the instrument is Los Angelis time zone and I am on the East Coast.
To boot, the time zone can only be updated in Configuration Manager as of now and not in RALS. It seems you have to do this first and then once you get back on the network, then it will pick up the time.
Moral of the story- if it gets sent in for service, ALWAYS, change the date and time in the instrument to make sure it is correct, even if it is just by a few minutes

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Stacy Stoeger
almost 2 years ago
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