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	09/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 27sep2018 to assess the instrument test well images in question, and determined that they appeared visually negative.No errors were noted in the instrument event log.The immucor laboratory reviewed dhr records on 04oct2018 because the product had already expired, and determined that the product had performed as expected at the time of product release.(b)(4).
Event or Problem Description
On (b)(6) 2018, an immucor employee reported on behalf of a customer site an unexpectedly negative antibody identification when using capture-r ready-id, when used on a galileo echo instrument on (b)(6) 2018.

• 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: 7992440
• Report Number: 1034569-2018-00230
• Device Sequence Number: 1255755
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/22/2018

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: 09/18/2018
• Device Catalogue Number: 0066204
• Device Lot Number: ID363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR