MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN 3; REAGENT RED BLOOD CELLS

Catalog Number	0066803
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch files retrieved from echo serial number (b)(4): batch 72659 ((b)(4), r771, 221703).Sample 18770988.Sci- neg result- visually negative.Scii - neg result- visually positive (k+).Sciii- neg result- visually negative.Control well resulted as expected.Batch 72662 ((b)(4), r771, 221703).Sample 16-g254b030.Sci- neg result- visually negative.Scii - neg result- visually positive (k+).Sciii- neg result- visually negative.Control well resulted as expected.Visually the k+ cell appears visually positive and has resulted as negative per (b)(4) we are aware of some instances on the echo where the instrument may generate a negative well interpretation for capture-r® ready-screen® or capture-r® ready-id® assays and subsequent visual interpretation of those reactions are weak positive or questionable (equivocal).Confirmed the reactivity of the k antigen, on the echo, with retention anti-k (1:128 dilution) using retention capture-r ready-screen (3), lot r771 and capture-r ready indicator red cell, lot 221703.Controls performed as expected and all cells resulted as expected.Retention performed as expected.Performed an antibody screen on the echo with customer's submitted sample, 18770988, using retention capture-r ready-screen (3), lot r771 and capture-r ready indicator red cell, lot 221703.Controls performed as expected.Customer's sample resulted the expected positive reaction on cell 2 k+.Reaction was 3+.We were unable to reproduce customer's observation.
Event or Problem Description
On (b)(6) 2016 a customer reported unexpected negative results when testing a patient sample using capture-r ready-screen 3 (crrs 3) on the galileo echo instrument serial number (b)(4).The sample was from a patient with a history of anti-kell.

• Brand Name: CAPTURE-R READY-SCREEN 3
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6015210
• Report Number: 1034569-2016-00258
• Device Sequence Number: 13539994
• Product Code: KSZ
• UDI-Device Identifier: 10888234001416
• UDI-Public: 10888234001416
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: STN 102707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/10/2016

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: 11/15/2016
• Device Catalogue Number: 0066803
• Device Lot Number: R771
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2016
• Initial Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 70