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

Catalog Number	0006428
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019 immucor performed an antibody screen qc on an echo lumena using retention capture-r ready-screen 3 lot number r068 and retention capture-r indicator cells lot number 221345.Controls performed as expected.Retention product performed as expected.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported unexpected negative screen and id results on the echo lumena instrument.

• Brand Name: CAPTURE-R READY INDICATOR CELL
• 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: 8808940
• Report Number: 1034569-2019-00119
• Device Sequence Number: 18913820
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/19/2019

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: 07/14/2019
• Device Catalogue Number: 0006428
• Device Lot Number: 221345
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR