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

Catalog Number	0006454
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(4) 2018 to assess test well images in question, which showed that they were visually negative.The immucor laboratory tested retention product on (b)(6) 2018 which performed as expected.The immucor laboratory also tested a returned blood sample from the customer site (b)(6) against retention products dp099m and 221058, which yielded unexpectedly negative outcomes, which reproduced the customer's observation.
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpected negative antibody identification when using capture-r ready-id extend i when used on a galileo echo instrument, when tested on (b)(6) 2018.

• Brand Name: CAPTURE-R READY-ID EXTEND I
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7426445
• Report Number: 1034569-2018-00093
• Device Sequence Number: 1716433
• Product Code: KSZ
• UDI-Device Identifier: 10888234000662
• UDI-Public: 10888234000662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/5030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: 04/03/2018
• Device Catalogue Number: 0006454
• Device Lot Number: DP099M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR