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

Catalog Number	0066815
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No blood sample or product was returned to immucor from the customer site for immucor laboratory assessment.The immucor (b)(4) office confirmed the information from the (b)(6) customer site on 18jul2018.(b)(4).
Event or Problem Description
On (b)(6) 2018, a (b)(6) customer reported an unexpectedly negative antibody screen when using capture-r ready-screen (3) with an echo lumena 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: 7759387
• Report Number: 1034569-2018-00182
• Device Sequence Number: 1319857
• Product Code: KSZ
• UDI-Device Identifier: 10888234001478
• UDI-Public: 10888234001478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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: 08/21/2018
• Device Catalogue Number: 0066815
• Device Lot Number: J104
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1