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

Catalog Number	0066204
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory tested retention product on (b)(4) 2019, which performed as expected.The immucor laboratory also received a blood sample from the customer site (number (b)(6)) and tested it against lot specific retention product (id372 and 221240) on (b)(4) 2019 which yielded a negative testing outcome.Immucor technical support used a remote electronic connection method on (b)(4) 2019 to assess the testing instrument used and found the instrument test well images in question for id372 to be visually negative.The instrument test well images in question for r027 on (b)(4) 2019 were visually weakly positive.The camera report was acceptable and the event log showed no errors.An immucor field service engineer (fse) visited the customer site to assess the testing instrument used on (b)(4) 2019 and found that the shake had to be adjusted, which was done, and the washer module was replaced due to discolored connections.The internal immucor tracking record number is (b)(4).
Event or Problem Description
On (b)(6) 2019, a customer site reported an unexpectedly negative antibody identification outcome when used on a galileo echo 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: 8267993
• Report Number: 1034569-2019-00032
• Device Sequence Number: 11312188
• Product Code: KSZ
• UDI-Device Identifier: 10888234001140
• UDI-Public: 10888234001140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 0066204
• Device Lot Number: ID372
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR