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

Catalog Number	0066814
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples or products were returned.Capture-r ready-screen 3 lot number e407 had expired prior to immucor receiving this complaint for investigation and no relevant retention testing was performed while this lot was in date.The dhr for capture-r ready-screen 3 lot number e407 shows that the cw antigen was confirmed as present on cell 1 at final release testing performed by quality control using final plate product.Dhr quality found all specifications to be acceptable and released this lot to market.Product performed as expected prior to release.There are no other complaints of unexpected negative reactivity associated with capture-r ready-screen 3 lot number e407.The immucor internal record reference for this event is pr# (b)(4).
Event or Problem Description
On january 8, 2021 a customer in (b)(6) reported an unexpected negative screen result with capture-r ready-screen 3 on the neo iris instrument.

• Brand Name: CAPTURE-R READY-SCREEN 3
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 11290041
• Report Number: 1034569-2021-00006
• Device Sequence Number: 17294970
• Product Code: QHT
• UDI-Device Identifier: 10888234001461
• UDI-Public: 10888234001461
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: BL 102707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: Health Professional
• Device Expiration Date: 01/06/2021
• Device Catalogue Number: 0066814
• Device Lot Number: E407
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1