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	03/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 11mar2019 to assess the testing instrument in question, and found the test well images in question were visually negative.The camera report was acceptable, and there were no event log errors.The immucor laboratory tested retention product on 14mar2019, and found the retention product to be performing as expected.The immucor laboratory also received a blood sample from the customer site ((b)(4)) and tested it with retention of dp106 and 221289, and the outcome was negative with the customer's blood sample, which reproduced the customer's observation.Another blood sample was received after the original immucor workup, and this blood sample was tested with capture-r select and panocell-10 lot number 05529, which yielded weakly 1+ reactivity with homozygous cells.Due to the patient history of recent immunization by pregnancy, the blood sample was treated with 0.01m dtt.The controls worked as expected, but no neutralization was observed by peg antiglobulin test.Neat patient sample showed 2+ anti-fyb activity in peg antiglobulin test.The dtt dilution control reacted 2+ at peg antiglobulin test.The confluence of these dtt testing outcomes directed towards the presence of a weakly reacting igg anti-fyb.An immucor field service engineer (fse) visited the customer site on 11mar2019 to assess the testing instrument, which performed as expected.The internal immucor record tracking number is (b)(4).
Event or Problem Description
On (b)(6) 2019, a customer site reported an unexpectedly negative antibody identification when using capture-r ready-id extend i when used on a galileo echo instrument, when tested on (b)(6) 2019.

• 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: 8484201
• Report Number: 1034569-2019-00072
• Device Sequence Number: 1784496
• Product Code: KSZ
• UDI-Device Identifier: 10888234000662
• UDI-Public: 10888234000662
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: 04/30/2019
• Device Catalogue Number: 0006454
• Device Lot Number: DP106
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR