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	Test Result (2695)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot # continued: r097,r099,r095,j115,j117,r082,id383,221350,r098,id385,e365,r112,r110,r111,r100,r105.
Event or Problem Description
This report summarizes malfunction events.A review of the events indicated that nineteen (35) patient sample tests using the capture-r ready screen 3 reagent on automated blood bank systems produced unexpected negative results for specific antibodies.The results represent false negatives due to prior patient histories or, testing completed by other methods that demonstrated the presence of the specific antibodies.The malfunctions did not show positive results as expected for the anti-jka antibody on five (5) occasions; the anti-fya antibody on two (2) occasions; the anti-c antibody on two (2) occasions; the anti-c antibody on two (2) occasions; the anti-d antibody on two (2) occasions; the anti-e antibody on five (5) occasions; the anti-k antibody on seven (7) occasions; the anti-fyb antibody on four (4) occasions; the anti-jkb antibody on three (3) occasions; the anti-s antibody on two (2) occasions and the anti-cw antibody on two (2) occasions.Subsequent testing of reagent retention lots, reviews of design history records and reagent antigen validation testing of the initial bulk product used for commercial vialing showed acceptable results.Through post event tests and investigations, no specific causes were determined for the malfunctions.

• Brand Name: CAPTURE R READY SCREEN 3
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 9644460
• Report Number: 1034569-2020-00004
• Device Sequence Number: 19190424
• Product Code: QHT
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5045
• Number of Events Summarized: 35
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0066813
• Device Lot Number: J114,J112,R086,E354,R080,R092
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1