MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS

Catalog Number	0006427
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On may 6, 2019 immucor technical support used a remote electronic connection method to assess files on gallieo echo v2.0 instrument serial number (b)(4).On may 7, 2019 an immucor field service engineer inspected gallieo echo v2.0 instrument serial number (b)(4) at the customer site.An unexpected reactions checklist was performed and the instrument was found to be within specifications and operating as expected.(b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported an unexpected negative antibody screen result on a gallieo echo v2.0 instrument.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8624725
• Report Number: 1034569-2019-00098
• Device Sequence Number: 13936977
• Product Code: KSF
• UDI-Device Identifier: 10888234000594
• UDI-Public: 10888234000594
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK020053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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: 05/16/2019
• Device Catalogue Number: 0006427
• Device Lot Number: 221309
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR