MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY INDICATOR RED CELLS; ANTIGLOBULIN COATED RED CELLS

Catalog Number	0006428
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full number for the product in question is (b)(4) (1/27/2003).Immucor technical support used a remote electronic connection method on 04jan2019 to assess the testing instrument in question.The instrument test well images in question were visually negative, the camera calibration was in range and the event log showed no relevant information.Because the product was already expired at the time of immucor being made aware of this situation, the immucor laboratory determined that retention testing had previously already been performed when the product was in-date, but not on an echo lumena instrument, but rather a galileo echo instrument, and at that time, under those circumstances, the retention product performed as expected.The internal immucor record tracking number for this record is (b)(4).
Event or Problem Description
On (b)(6) 2019, a customer site reported an unexpectedly negative antibody screen when using capture-r ready indicator red cells on an echo lumena instrument, when tested on (b)(6) 2018, which led to an event being categorized as a delayed hemolytic transfusion reaction.

• Brand Name: CAPTURE-R READY INDICATOR RED CELLS
• Common Device Name: ANTIGLOBULIN COATED RED CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8261112
• Report Number: 1034569-2019-00029
• Device Sequence Number: 2056288
• Product Code: KSF
• UDI-Device Identifier: 10888234000600
• UDI-Public: 10888234000600
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BK020053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/23/2018
• Device Catalogue Number: 0006428
• Device Lot Number: 221216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Weight: 57