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

Catalog Number	0066204
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support received an email of the batch testing records in question, via the immucor employee at the customer site, to assess the test well images in question, which appeared visually as negative.The immucor laboratory tested retention product on (b)(6) 2018, which performed as expected.Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project (b)(4).The immucor technical communication (b)(4) is being used by the lab to visually confirm all negative assay events reported by the echo instrument.The internal immucor record tracking number for this report is (b)(4).The customer site had sent blood samples to the immucor laboratory for testing on (b)(6) 2018, but unfortunately both of these two (2) blood samples were unlabeled, and therefore could not be tested.Note: the customer site reported this event independently to the fda under mw5076325 on (b)(6) 2018.The fda subsequently alerted immucor of this customer report on a letter dated (b)(6) 2018.
Event or Problem Description
On (b)(6) 2018, an immucor employee reported on behalf of a customer site an unexpectedly negative antibody identification when using capture-r ready-id when used on a galileo echo instrument, when tested on (b)(6) 2018.

• Brand Name: CAPTURE-R READY-ID
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7462510
• Report Number: 1034569-2018-00112
• Device Sequence Number: 1252044
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: Medical Technologist
• Device Expiration Date: 05/15/2018
• Device Catalogue Number: 0066204
• Device Lot Number: ID356
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR