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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020 immucor technical support used a remote electronic connection method to access galileo neo serial number (b)(4).Review of the (b)(6) 2020 results confirmed that visually it appeared to be negative; no errors were noted in event log.On (b)(6) 2020 an immucor field service engineer (fse) examined the instrument at the customer site.The fse completed the unexpected reactions checklist successfully.The fse adjusted the roi's and completed daily maintenance.The fse then ran abo and 3 cell screen qc which returned qualified results.The fse also ran abo and 3 cell screen assays on 4 patient samples which provided acceptable results.On november 23, 2020 immucor confirmed presence of the jka antigen on cells 1 and 2 of retention capture-r ready-screen lot r180 in manual capture using retention capture-r indicator cell lot 221660 with retention anti-jka lot dl189543.Controls performed as expected.Cells 1 and 2 resulted positive as expected.Retention product performed as expected.
Event or Problem Description
On (b)(6) 2020 a customer reported an unexpected negative screen result with capture-r ready-screen 3 on the galileo neo instrument.

• 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: 11039727
• Report Number: 1034569-2020-00060
• Device Sequence Number: 1034653
• Product Code: QHT
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2020
• Device Catalogue Number: 0066813
• Device Lot Number: R180
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1