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	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implicated product had already expired when a dhr review was performed on 24jul2018, which showed that the presence of the lua antigen was confirmed before product release to market, and all other specifications were deemed acceptable before the product was released.The customer sent scans of two (2) instrument paper reports to immucor technical support for assessment which were dated (b)(6) 2018 (sample (b)(6)) and (b)(6) 2018 (sample (b)(6)).The customer sent three (3) blood samples to the immucor laboratory, from the same patient, for investigation on 19jul2018.The blood sample identification numbers for those three (3) blood samples were (b)(6) (collection date (b)(6) 2018), (b)(6) (collection date (b)(6) 2018) and (b)(6) (collection date (b)(6) 2018).For the blood sample (b)(6) (collection date (b)(6) 2018), a gel card screen was negative, gel card antibody identification was 2+ positive for lua antigen positive red blood cells, capture antibody screen and identification was negative, and known lua antigen positive red blood cells tested on capture-r select (lot number sc561) were negative.For the blood sample (b)(6) (collection date (b)(6) 2018), a gel card screen was 1+ positive with lua antigen positive red blood cells, gel card antibody identification was 2+ positive for lua antigen positive red blood cells, capture antibody identification with id (b)(6) was positive (well number 4), and known lua antigen positive red blood cells tested on capture-r select (lot number sc561) were negative.The lot number of indicator cells used was 221096.For the blood sample (b)(6) (collection date (b)(6) 2018), a gel card screen was 1+ positive with lua antigen positive red blood cells, gel card antibody identification was 2+ positive for lua antigen positive red blood cells, and capture antibody identification with id (b)(6) and also capture antibody screen were negative.The lot number of indicator cells used was 221116.(b)(4).
Event or Problem Description
On 19jul2018, it was determined that a european (b)(6) report from (b)(6) 2018 was reportable as an unexpected negative antibody identification when using capture-r ready-id when used on a galileo neo instrument, when tested on (b)(6) 2018.

• 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: 7736458
• Report Number: 1034569-2018-00180
• Device Sequence Number: 11408036
• 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
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 07/10/2018
• Device Catalogue Number: 0066214
• Device Lot Number: ID359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1