Does anyone out there use the PROVUE for AHG crossmatches? If so, have you ever had a case where the PROVUE called a unit compatible, but when the tech repeated it using manual gel, the manual gel card got 2+ incompatible? We just had this happen (long, FDA reportable story ) and we are now wondering why this could happen. Any thoughts or ideas, please respond. Also, if you are willing to share your procedure for using the PROVUE for crossmatches, that would be great. We simply empty one seg into a labeled tube, and program the machine. Are we missing a crucial step? Thank you.

We empty one segment in 12 X 75 tube and spin it to pack the cells before running crossmatch on ProVue. We routinely do not do crossmatches on ProVue. We use manual gel.

the patient you did crossmatch has any antibody? was the unit postive for corresponding antigen?

I guess I should clarify- Yes the patient had an antibody, and yes the units crossmatched had the corresponding antigen. (Inexperienced Techs did not follow SOP or GMP- thus the FDA issue) SInce the PROVUE called the units compatible, the techs did not question the results, and issued the products for transfusion without antigen testing.

But, that is our concern- Why would the PROVUE call these units compatible? Like I said before, the tech got a 2+ incompatible when she used our manual gel process.

Did you repeat the crossmatches on the Provue with both pre and post transfusion samples? We use manual gel and I also would be concerned if the Provue missed something that was 2+ using manual gel.

We do AHG crossmatches on the ProVue, I will be happy to share my procedure with you. We do the same as you, label a 12 x 75 plastic tube with a bar code from the donor unit, add cells from a seg, program the PV for an AHG XM. We validated PV against manual gel at the bench with no problems.

My best wishes to you in responding to the FDA, I too have had that experience, it is not fun. My work e-mail is Mary_Mendel@ssmhc.com, I can send you the procedure from this address.

There had to have been an error when the donor units were loaded onto the PV, or the wrong seg put into the tube or some type of error in the XM process. Not that the PV is infallable, but I have found in my MANY years of BB expereince that the steps of the process where humans are involved is where the biggest risk of a mistake occur.

Hang in there, it will get better, believe me!

Yes, we did the crossmatch with both pre and post samples, and in both cases, the PROVUE called them compatible. Several different techs have run the same samples, and in all cases, the PROVUE called the units compatible. (DId I mention that the antibody was an anti-e, and that the PROVUE called two out of 7 units compatible? What are the chances of that happening??)

We have since done some correlations with antibody screens, and again, the PROVUE is missing the weaker reactions. This time, I saved the cards from the PROVUE, and there is no comparison to the manual cards.

We have a tech from Rochester coming to look at this. I will keep you posted.

Thanks

Good luck!. We had same problem, tech coming from Rochester didn't help. We do not do crossmatches on ProVue alone. Some time we use ProVue to screen units and repeat crossmatch with manual gel.