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

Catalog Number	0066214
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(6) 2017 to assess test well images in question, which showed that they were visually negative.The immucor laboratory tested retention product on 05oct2017, which performed as expected.
Event or Problem Description
On (b)(6) 2017, an immucor employee visiting a customer site reported, on behalf of the customer site, an unexpected negative antibody identification when using capture-r ready-id when used on a galileo 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: 6946274
• Report Number: 1034569-2017-00279
• Device Sequence Number: 1208615
• Product Code: KSZ
• UDI-Device Identifier: 10888234001188
• UDI-Public: 10888234001188
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

1 Device 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: 10/17/2017
• Device Catalogue Number: 0066214
• Device Lot Number: ID344
• 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: 09/26/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No