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	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(6) 2019 to assess the testing instrument used.The immucor laboratory tested retention product on 16jan2019, which performed as expected.The immucor laboratory also received a blood sample from the customer site for testing ((b)(6)) which was tested on 16jan2019 against retention product for id372 and indicator cells 221241 which reacted equivocally by automated method.Manual test tube testing was performed on that blood sample which reacted weakly positive at room temperature and 37 degrees c, but negative at indirect antiglobulin test.The internal immucor tracking record number is (b)(4).
Event or Problem Description
On (b)(4) 2019, a (b)(6) customer reported, via email, an unexpectedly negative antibody identification outcome when used on a galileo neo instrument, when tested on (b)(6) 2019.

• 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: 8264381
• Report Number: 1034569-2019-00030
• Device Sequence Number: 2321725
• Product Code: KSZ
• UDI-Device Identifier: 10888234001188
• UDI-Public: 10888234001188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2019

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: 02/19/2019
• Device Catalogue Number: 0066214
• Device Lot Number: ID372
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1