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 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

Customer reports unexpected reactivity on (b)(6) 2022 when performing daily qc for the antibody detection test using search-cyte tcs 0.8% rrbcs lot 644722007, expiry 14may2022 with dg gel 8 anti-igg cards lot 21027.01.1, expiry 2022-09 and dg gel extended control lot qc0022007, expiry 14may2022.Qc kit was opened the day before, 09may22, and all qc results were as expected.Logs provided reveal no mechanical issues from the dg59 logs nor errors recorded in the erytradebug executor logs.Qc testing at @09:49 showed the following unexpected reactions: 1.Qc tube 02, cell i = 1+, cell ii = 1+, card (b)(4), wells 4&5.2.Qc tube 03, cell i = ?, cell ii = 1+, card (b)(4), wells 5&6.3.Qc tube 04, cell i = 3+, card (b)(4), well 1.Repeat testing at @ 10:22 showed the following unexpected reactions: 1.Qc level 03, cell ii = 1+, card (b)(4), well 5.After analyzing the results, it is found out that all unexpected positive results correspond to d positive cells and d negative cells do not show unexpected positive results.The user performed previously a d typing using anti-d antisera, so the observations of a positive antibody detection test immediately following the use of a potent anti-d typing reagent, could be consistent with suspected carryover.The reported scenario, unexpected results in qc testing, does not impair patient safety.There are no patient samples involved, so there is no possibility of 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 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 unexpected reactivity on (b)(6) 2022 when performing daily qc for the antibody detection test using search-cyte tcs 0.8% rrbcs lot 644722007, expiry 14may2022 with dg gel 8 anti-igg cards lot 21027.01.1, expiry 2022-09 and dg gel extended control lot qc0022007, expiry 14may2022.Qc kit was opened the day before, (b)(6) 2022, and all qc results were as expected.

Manufacturer Narrative

Customer reports unexpected reactivity on (b)(6) 2022 when performing daily qc for the antibody detection test using search-cyte tcs 0.8% rrbcs lot 644722007, expiry 14may22 with dg gel 8 anti-igg cards lot 21027.01.1, expiry 2022-09 and dg gel extended control lot qc0022007, expiry 14may22.Qc kit was opened the day before, (b)(6) 2022, and all qc results were as expected.Qc testing at @09:49 showed the following unexpected reactions: 1.Qc tube 02, cell i = 1+, cell ii = 1+, card 414109220270134967, wells 4&5; 2.Qc tube 03, cell i = ?, cell ii = 1+, card 414109220270134758, wells 5&6; 3.Qc tube 04, cell i = 3+, card 414109220270134967, well 1.Repeat testing at @ 10:22 showed the following unexpected reactions: 1.Qc level 03, cell ii = 1+, card 414109220270134726, well 5.After analyzing the results, it is found out that all unexpected positive results correspond to d positive cells and d negative cells do not show unexpected positive results.The user performed previously a d typing using anti-d antisera, so the observations of a positive antibody detection test immediately following the use of a potent anti-d typing reagent, could be consistent with suspected carryover.There are no patient samples involved, so there is no possibility of 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 four qc samples for d typing+dat technique and afterwards an antibody screening technique for the same four qc samples.Following these steps, with combinations of different lots of reagent rbcs and different lots of anti-igg cards, the unexpected positive result was intermitently 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.

Event Description

Customer reports unexpected reactivity on (b)(6) 2022 when performing daily qc for the antibody detection test using search-cyte tcs 0.8% rrbcs lot 644722007, expiry 14may22 with dg gel 8 anti-igg cards lot 21027.01.1, expiry 2022-09 and dg gel extended control lot qc0022007, expiry 14may22.Qc kit was opened the day before, (b)(6) 2022, and all qc results were as expected.

• 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: 15182963
• MDR Text Key: 305275159
• Report Number: 3002772505-2022-00004
• 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: 08/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other