MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN 3; REAGENT RED BLOOD CELLS

Catalog Number	0066813
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Chills (2191)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On march 16, 2021 immucor received five return samples.Four tubes contained whole blood and one tube was received broken.Two tubes were collected on (b)(6) 2021 at 1455 one from an edta and the other a red top sample.These two tubes were labeled as 831706pre a with a plasma and serum written on the tube.The other two tubes were collected on (b)(6) 2021 one tube at 1538 the other at 1807.These tubes were labeled as 831706post a and 831706post b.On (b)(6) 2021 immucor confirmed the presence of the k antigen on retention crrs3 lot r227.Capture method was used to test crrs3 lot r227 with retention crrirc lot 221719 and retention anti-k lot 054020.Cell1 resulted positive for the k antigen as expected.Controls performed as expected.Retention product performed as expected.Testing was performed on the echo.On (b)(6) 2021 immucor performed a screen assay on the echo lumena using returned samples, 831706pre a and 831706post b, with retention crrs3 lot r227 and retention crrirc lot 221719.Return sample 831706pre a resulted negative with cells 2 and 3.Cell 1 gave an equivocal result and was visually interpreted as positive.Return sample 831706post b resulted negative with all cells.Controls performed as expected.It appears that the anti-k may be trying to show dosage.Immucor performed an extend i assay on the echo lumena using returned samples 831706pre and 831706post with retention capture-r ready-id ext i lot number dp119: controls performed as expected; both returned samples resulted negative with all cells.Immucor then performed tube testing using selected red cells from panoscreen iii lot 04421 using returned samples 83170pre and 83170post.Retention gamma peg lot 336040 was used for enhancement.All tubes were read and graded at the ahg phase of testing.Sample 831706 pre resulted negative with cells 1 and 2 (k antigen negative); and cell 3 resulted positive (2+) (k antigen positive).Sample 831706post resulted negative with cells 1 and 2 (k antigen negative); and cell 3 resulted positive (3+) (k antigen positive).The patient anti-k is showing dosage.Immucor was able to reproduce customer's observation with returned sample.However investigation did not identify a product deficiency.Retention product performed as expected.The anti-k in this sample is showing dosage, which explains negative reactivity with the k+k+ cells on the capture screen and id products.This issue is a sample related issue.The internal immucor record for this event is (b)(4).
Event or Problem Description
On march 15, 2021 a customer reported that a patient had a transfusion reaction consisting of chills, rigors, and elevated blood pressure following transfusion of a half unit of k+ prbc.Patient presented (b)(6) 2021 as antibody screen negative.Patient received multiple transfusions; on final unit (which was (b)(6) 2021) a transfusion reaction occurred.

• Brand Name: CAPTURE-R READY-SCREEN 3
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 11657055
• Report Number: 1034569-2021-00010
• Device Sequence Number: 3520322
• Product Code: QHT
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: BL 102707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2021
• Device Catalogue Number: 0066813
• Device Lot Number: R227
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR