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

Catalog Number	0066214
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 01sep2018 to assess the instrument test well images in question, and determined that they appeared visually negative.No errors were noted in the instrument event log.The immucor laboratory tested retention product on 14sep2018, which performed as expected.The immucor laboratory also received a blood sample from the customer site ((b)(4)) and tested it on 14sep2018 against retention product of id363, which yielded the same unexpectedly negative outcome as the customer had obtained.The immucor laboratory also tested that same returned blood sample with antibody screen lot number r988, which also yielded an unexpectedly negative outcome.An immucor field service engineer (fse) visited the customer site on 04sep2018 to assess the echo lumena testing instrument and determined that the instrument was operating as expected.(b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly negative antibody identification when using capture-r ready-id, when used on an echo lumena 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: 7898032
• Report Number: 1034569-2018-00211
• Device Sequence Number: 18903319
• Product Code: KSZ
• UDI-Device Identifier: 10888234001188
• UDI-Public: 10888234001188
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: No Information
• Device Expiration Date: 09/18/2018
• Device Catalogue Number: 0066214
• Device Lot Number: ID363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 82