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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support reviewed photographed instrument-on-screen reports provided by the customer on (b)(6) 2018 and determined that the test well images appeared visually negative.The immucor laboratory tested retention product on 29nov2018 which performed as expected.The immucor laboratory received the blood sample from the customer ((b)(4)) and tested it against immucor retention product, which yielded an unexpectedly negative outcome.That blood sample was also tested by immucor, by manual test tube method using panocell-10 (lot number 42547) and ahg (lot number 7012007310), which yielded questionable (+/-) outcomes.In this immucor laboratory investigation, the customer's observations were reproduced.The internal immucor record number is (b)(4).
Event or Problem Description
On (b)(6) 2018, a european (b)(6) customer reported an unexpectedly negative antibody screen with capture-r ready-screen (3), when tested on a galileo 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 30091 5625
• MDR Report Key: 8138113
• Report Number: 1034569-2018-00274
• Device Sequence Number: 216913
• Product Code: KSZ
• UDI-Device Identifier: 10888234001461
• UDI-Public: 10888234001461
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: 102707/5045
• 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): 12/06/2018

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: 01/09/2019
• Device Catalogue Number: 0066814
• Device Lot Number: E315
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1