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

Catalog Number	0066803
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On february 19, 2019 immucor technical support used a remote electronic connection method to review test records from the relevant run on the neo instrument serial number (b)(4).On february 21, 2019 a similar remote connection was made the echo instrument serial number (b)(4).No errors during processing were noted.Following consultation with the customer, the possibility could not be ruled out that the new antibody was a mix of igg and igm making the detectable amount of igg right on the edge of detection (this would not affect the peg testing).The internal immucor record for this event is (b)(4).
Event or Problem Description
On february 15, 2019 a customer reported unexpected negative screen results using capture-r ready-screen 3 on the 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 30091 5625
• MDR Report Key: 8410165
• Report Number: 1034569-2019-00053
• Device Sequence Number: 16597011
• Product Code: KSZ
• UDI-Device Identifier: 10888234001416
• UDI-Public: 10888234001416
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 102707/5045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/05/2019
• Device Catalogue Number: 0066803
• Device Lot Number: R031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR