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

Catalog Number	0066813
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support could not use a remote electronic connection method to assess the testing instrument in question because the customer site was a va facility and had not such linkage.However, printed reports were provided and information was obtained that way.The immucor laboratory tested retention product on 13jun2019, which performed as expected.An immucor field service engineer (fse) visited the customer site on 17jun2019 to assess the testing instrument and found it to be operating as expected.(b)(4).
Event or Problem Description
On (b)(6) 2019, an immucor employee reported, on behalf of a customer site an unexpectedly negative antibody screen when using capture-r ready-screen (3) with a galileo echo instrument, when tested on (b)(6) 2019.

• 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: 8739517
• Report Number: 1034569-2019-00110
• Device Sequence Number: 19474355
• Product Code: KSZ
• UDI-Device Identifier: 10888234001454
• UDI-Public: 10888234001454
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5045
• 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): 06/27/2019

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: 08/06/2019
• Device Catalogue Number: 0066813
• Device Lot Number: R063
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR