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

Catalog Number	0006440
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No blood sample or electronic connection was available or possible.
Event or Problem Description
On (b)(6) 2017, a customer site, reported an unexpectedly negative antibody screen when tested on a manual capture workstation.

• Brand Name: CAPTURE-R READY-SCREEN (I AND II)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6793017
• Report Number: 1034569-2017-00196
• Device Sequence Number: 18857159
• Product Code: KSZ
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/14/2017

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: 09/05/2017
• Device Catalogue Number: 0006440
• Device Lot Number: X470
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR