MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (I AND II); REAGENT RED BLOOD CELLS

Catalog Number	0006440
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on 27feb2018 to assess the instrument test well images in question, which appeared to have a smaller button of indicator cells.The immucor laboratory tested retention product on 07mar2018 which performed as expected.The immucor laboratory also tested some returned blood samples from the customer site on 07mar2018.Of the three (3) blood samples that were supplied by the customer site, two (2) were of insufficient liquid volume for testing, and the third blood sample was hemolyzed and so therefore not suitable for testing on a galileo neo instrument.Therefore this third hemolyzed blood sample was tested by manual capture testing with retention product, which yielded unexpected negative outcomes, consistent with the customer's findings.An immucor field service engineer (fse) visited the customer site to assess the instrument used for testing.The fse found pipettor number 3 dispensing at a low rate, and therefore replaced it.The fse found the lls board in need of replacement, so therefore the fse replaced it.The camera mirror and diffusor required cleaning and the rois needed optimization, which were performed by the fse.The fse found the lamp not performing as expected, and it was therefore replaced by the fse.After ths work by the fse, the galileo neo instrument was checked by the fse as operating as expected, and this instrument was then returned back the customer for routine use.
Event or Problem Description
On 27feb2018, an immucor employee visiting a customer site, reported on behalf of the customer site, an unexpectedly negative antibody screen when tested on a galileo neo instrument, when tested on (b)(6) 2018.

• Brand Name: CAPTURE-R READY-SCREEN (I AND II)
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 7361649
• Report Number: 1034569-2018-00075
• Device Sequence Number: 1274284
• Product Code: KSZ
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: Medical Technologist
• Device Expiration Date: 04/18/2018
• Device Catalogue Number: 0006440
• Device Lot Number: X479
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR