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

Catalog Number	0066214
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A synopsis of the testing for crrid batch 618 for sample (b)(6) using crrid lot id311 with cell lot 221707 is as follows: (b)(6).Control wells reacted as expected.Unexpected negative reactivity is noted for cells 1, 2, 3, 5, 6, 7, 9, and 12.Confirmed the reactivity of the fya and e antigen on retention capture-r ready-id, lot id311, in manual capture, using retention capture-r ready indicator red cell, lot 221709, anti-fya (1:16 dilution), and anti-e, lot tn0034-b (1:16 dilution).Controls performed as expected and all cells tested, exhibited the expected reactivity.Retention performed as expected.A service call was made and the instrument is operating within specifications.
Event or Problem Description
On (b)(6) 2016, a customer reported an unexpected negative result when testing patient sample (b)(6) with capture-r ready-id on the galileo echo instrument.Sample is known to contain an anti-fya.No adverse event occurred.Testing was for validation purposes only.

• Brand Name: CAPTURE-R READY-ID
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6057846
• Report Number: 1034569-2016-00274
• Device Sequence Number: 863270
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 10/26/2016

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: Medical Technologist
• Device Expiration Date: 11/15/2016
• Device Catalogue Number: 0066214
• Device Lot Number: ID311
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR