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

Catalog Number	0066214
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 17sep2017 to assess test well images in question, which showed they were visually negative.The immucor laboratory tested retention product on 03oct2017, which performed as expected.The immucor laboratory also tested returned blood samples from the customer site on 03oct2017 which yielded unexpected negative outcomes, and therefore the customer's blood sample testing observations were reproduced.An immucor field service engineer (fse) visited the customer site on 25sep2017 to assess the testing instrument in question, and determined that the instrument was operating as expected.
Event or Problem Description
On (b)(6) 2017, a customer site reported an unexpected negative antibody identification when using capture-r ready-id when used on a galileo echo instrument.

• 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: 6936482
• Report Number: 1034569-2017-00273
• Device Sequence Number: 19156824
• Product Code: KSZ
• UDI-Device Identifier: 10888234001188
• UDI-Public: 10888234001188
• 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: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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: 10/03/2017
• Device Catalogue Number: 0066214
• Device Lot Number: ID343
• 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: 09/17/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR