MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (POOLED CELLS); AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0066254
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019 immucor confirmed the presence of the dia antigen on retention capture-r ready-screen (pooled cells) lot number b045 in manual capture using retention capture-r indicator cell lot number 221369 with retention anti-dia lot number dia081910de.Controls performed as expected.Capture-r ready-screen (pooled cells) lot number b045, cell 1 di(a+), resulted positive as expected.Retention product performed as expected.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer in reported an unexpected negative result with capture-r ready-screen (pooled cells) on a galileo neo instrument.

• Brand Name: CAPTURE-R READY-SCREEN (POOLED CELLS)
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8903339
• Report Number: 1034569-2019-00129
• Device Sequence Number: 13985458
• Product Code: KSZ
• UDI-Device Identifier: 10888234001317
• UDI-Public: 10888234001317
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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: 07/24/2019
• Device Catalogue Number: 0066254
• Device Lot Number: B045
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1