MAUDE Adverse Event Report: DIAGNOSTIC GRIFOLS, S.A. ERYTRA EFLEXIS; AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM

Model Number DG-511

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

Customer reports one sample (2205406810) with unexpected positive results for antibody screening (2 cells screening with search-cyte plus 0.8%).This sample was just executed after a qc test for the dweak test with anti-d igm/igg (ref.210526).The sample 2205406810 was run on february 23, on eflexis using search-cyte plus 0.8% rrbcs lot 22003, exp.19 mar22 with dg gel anti-igg cards lot 21015.01, expiry 30 apr22.Both cells being d positive (results: cell i= ? and cell 2 = 3+).Testing was repeated and it was obtained that cell i = negative and cell ii = ?.Both test results were rejected.Customer repeated the test for a 3rd time obtaining negative results for both cells.As indicated, daily qc (dg extended control lot # qcx022003 exp 19/03/2022) was run for the d typing (igg) test profile using anti-d igm/igg immediately prior to the processing of sample 2205406810.No other samples were tested between the first and second tests for the affected sample.Between the second and third test for the sample, three other sample were processed: 2205407264, 2205407513, and 2205407214 and all three samples had negative antibody detection test results.The observations of a positive antibody detection test immediately following the use of a potent anti-d typing reagent, which diminishes in reactivity strength with each subsequent testing repeat, could be consistent with suspected carryover.However, as no troubleshooting was performed to confirm the observed reactivity was only due to carryover, and no other potential causes such as room temperature reactive antibodies, interfering substances, etc., carry-over cannot be directly established.The reported scenario, unexpected positive results in antibody screening, does not impair patient safety.The customer does not report any patient harm, nor transfusion reaction.The unexpected results were resolved after retesting.The customer has not complained of any other carry-over suspected unexpected results apart from the reported case.The customer customer configuration includes 4 wash cycles during d weak testing.Extensive testing was conducted, under worst case conditions, to establish the 4 washing cycles after using diagast anti-d igm+igg.This testing included the use of papainized rrbc and albumin 11%, which enhance reactivity and the detection of potential carry-over, even beyond of what can be expected in normal use conditions.It is deemed to be an improbable event and it is under investigation the potential causes of such unexpected event.A follow-up report will be issued with the results of the investigation performed.

Event Description

Customer reports one sample (2205406810) with unexpected positive results for antibody screening (2 cells screening with search-cyte plus 0.8%).This sample was just executed after a qc test for the dweak test with anti-d igm/igg (ref.210526).The sample 2205406810 was run on february 23, on eflexis using search-cyte plus 0.8% rrbcs lot 22003, exp.19 mar22 with dg gel anti-igg cards lot 21015.01, expiry 30 apr22.Both cells being d positive (results: cell i= ? and cell 2 = 3+).Testing was repeated and it was obtained that cell i = negative and cell ii = ?.Both test results were rejected.Customer repeated the test for a 3rd time obtaining negative results for both cells.As indicated, daily qc (dg extended control lot # qcx022003 exp 19/03/2022) was run for the d typing (igg) test profile using anti-d igm/igg immediately prior to the processing of sample 2205406810.No other samples were tested between the first and second tests for the affected sample.Between the second and third test for the sample, three other sample were processed: 2205407264, 2205407513, and 2205407214 and all three samples had negative antibody detection test results.

Event Description

Customer reports one sample ((b)(6)) with unexpected positive results for antibody screening (2 cells screening with search-cyte plus (b)(4)).This sample was just executed after a qc test for the dweak test with anti-d igm/igg (ref.(b)(4)).The sample (b)(6) was run on (b)(6), on eflexis using search-cyte plus (b)(4) rrbcs lot 22003, exp.19 mar22 with dg gel anti-igg cards lot 21015.01, expiry 30 apr22.Both cells being d positive (results: cell i= ? and cell 2 = 3+).Testing was repeated and it was obtained that cell i = negative and cell ii = ?.Both test results were rejected.Customer repeated the test for a 3rd time obtaining negative results for both cells.As indicated, daily qc (dg extended control lot # qcx022003 exp 19/03/2022) was run for the d typing (igg) test profile using anti-d igm/igg immediately prior to the processing of sample (b)(6).No other samples were tested between the first and second tests for the affected sample.Between the second and third test for the sample, three other sample were processed: (b)(6) and all three samples had negative antibody detection test results.

Manufacturer Narrative

Customer reports one sample ((b)(6)) with unexpected positive results for antibody screening (2 cells screening with search-cyte plus (b)(4)).This sample was just executed after a qc test for the dweak test with anti-d igm/igg (ref.(b)(4)).The sample 2(b)(6) was run on february 23, on eflexis using search-cyte plus (b)(4) rrbcs lot 22003, exp.19 mar22 with dg gel anti-igg cards lot 21015.01, expiry 30 apr22.Both cells being d positive (results: cell i= ? and cell 2 = 3+).Testing was repeated and it was obtained that cell i = negative and cell ii = ?.Both test results were rejected.Customer repeated the test for a 3rd time obtaining negative results for both cells.As indicated, daily qc (dg extended control lot # qcx022003 exp 19/03/2022) was run for the d typing (igg) test profile using anti-d igm/igg immediately prior to the processing of sample (b)(6).No other samples were tested between the first and second tests for the affected sample.Between the second and third test for the sample, three other sample were processed: (b)(6) and all three samples had negative antibody detection test results.The observations of a positive antibody detection test immediately following the use of a potent anti-d typing reagent, which diminishes in reactivity strength with each subsequent testing repeat, could be consistent with suspected carryover.The reported scenario, unexpected positive results in antibody screening, does not impair patient safety.The customer does not report any patient harm, nor transfusion reaction.The unexpected results were resolved after retesting.The customer has not complained of any other carry-over suspected unexpected results apart from the reported case.An investigation of the reported events has been carried out in diagnostic grifols facilities.Customer provided logs do not show any error regarding fluidics, samples identification, reagents identification, reagents level detection, pipetting, incubation or centrifugation processes.Logs inspection showed the correct dg clean consumption.After log analysis, the sequence of execution steps was determined: process 4 qc samples for d typing technique (with anti-d (rh1) igm + igg) and afterwards execute an antibody screening for a known negative selected sample.Following these steps, with combinations of different lots of reagent rbcs and different lots of anti-igg cards, the unexpected positive result was intermittently reproduced after several attempts.Even using the same instrument, reagents and cards the carry-over has not been always reproduced, showing a low rate of occurrence.In order to ensure an appropriate probe cleaning under any combination of factors, worst-case scenarios, although not expected in real use, were tested to determine the need of additional wash steps with dg clean.As a result of it, the probe wash steps will be modified in the next reagents pack v2.3.It has to be taken into account that a false positive in the antibody screening due to carry-over has no impact on patient´s safety.Since the aim of the antibody screening is to determine the presence of atypical red cell antibodies of likely clinical significance.When the antibody screening is positive, further testing is required to identify the responsible antibody (antibody identification).If panel results conflict with the antibody screening results, it requires the repetition of the tests performed.Additionally, if transfusion is necessary, a crossmatch test has to be performed to ensure the compatibility between the recipient's and donor's blood.Thus, the unexpected results obtained by the instrument will not result in a transfusion of unsuitable blood product.

• Brand Name: ERYTRA EFLEXIS
• Type of Device: AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM
• Manufacturer (Section D): DIAGNOSTIC GRIFOLS, S.A.; passeig fluvial, 24; parets del vallès, spain 08150 ; SP 08150
• Manufacturer (Section G): DIAGNOSTIC GRIFOLS, S.A.; passeig fluvial, 24; parets del vallès, spain 08150 ; SP 08150
• Manufacturer Contact: albert hernandez ; passeig fluvial, 24; parets del vallès, spain 08150 ; SP 08150
• MDR Report Key: 15182964
• MDR Text Key: 305250777
• Report Number: 3002772505-2022-00003
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK2000467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DG-511
• Device Catalogue Number: 210600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other