Report 2 of 2 customer reported a false negative result occurred with a dat done on a cord blood sample using poly gel cards lot# 013117005-01 exp.11/13/2017.Customer received a negative dat with the poly gel card and a positive 1+ dat reaction in tube using competitor's anti-igg reagent.Issue started on: (b)(6) 2017.Frequency: 2x.Microtubes/wells or cell (donor #) affected: random microwell.Methodology used: manual gel.Reaction grade obtained: negative.Customer was expecting: positive.Test repeated: yes.Result obtained by repeating: negative.Method used to repeat: manual gel.Customer cells were packed and manually washed prior to testing.Card/cassette type: poly gel cards, lot number: 013117005-01, expire: 11-13-2017.Qc type: ortho confidence kit, qc lot #: not provided.Qc expiration date: not provided.Last qc run: (b)(6) 2017.Sample type: edta.Visual appearance before use: acceptable.Pipette used: mts.Incubator type: mts.Cards/cassettes centrifugation: mts.Other relevant details: mother is a type 'o'.The baby is a type 'b'.The bilirubin was 14.8, with the baby under the bili-lights.Customer repeated the dat using the same lot of gel cards and received a negative reaction for the dat.Customer also tested the dat using mts anti-igg card, lot#101016001-06, exp.8/13/17 with a false negative occurring with the dat (see (b)(4)).Customer reported she followed ifu procedure as follows: prepared a red blood cell suspension of approximately 0.8% in mts diluent 2 (e.G., deliver 1.0 ml of mts diluent 2 into a test tube and pipetted 10 ml packed red blood cells into the diluent), mix gently.Label the gel card appropriately.Remove the foil seal from the mts anti-igg,-c3d card or from the individual microtubes to be used for testing.After removing the foil, visually inspect all gel cards with no issues.Added 50 ml of the 0.8% dilution to each microtube.Customer centrifuged the prepared cards in the mts centrifuge after centrifugation, removed the gel card (s) from the centrifuge.Observed, read macroscopically the front and back of each microtube for agglutination and/or hemolysis and record a negative reaction.Cts discussed with the customer that the hard spin of the tube reaction gave the weak reaction a 1+ dat using the immucor reagent.Customer is sending the sample to a reference lab for testing and she will call back to give update about the call.Customer called cts back to provide information on the sample eluate that the had anti-b.Customer will send a sample back to cts for further investigation.
|