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

Catalog Number	0066204
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 immucor technical support used a remote electronic connection method to transfer camera images, event logs and result batches for the issue described.The camera report appeared acceptable and no instrument problem was identified.On (b)(6) 2018 pi confirmed presence of the e antigen on cells 1, 3 and 6 of retention capture-r ready-id lot number id366 in manual capture with retention anti-e lot ab4929.Controls performed as expected.Positive results exhibited 3+ reactivity.Retention product performed as expected no sample or product was returned to immucor for evaluation.(b)(4).
Event or Problem Description
On (b)(6) 2018 a customer reported unexpected negative reactivity with capture-r ready-id on the echo instrument.

• 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: 8048186
• Report Number: 1034569-2018-00252
• Device Sequence Number: 1498536
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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: No Information
• Device Expiration Date: 11/13/2018
• Device Catalogue Number: 0066204
• Device Lot Number: ID366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1