MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-CMV INDICATOR RED CELLS; ANTI-IGG AND ANTI-IGM COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS

Catalog Number	0066238
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pi lab performed a cmv assay on the neo, using known cmv negative in house donor samples, using capture-cmv, lot c122 and capture-cmv indicator red cell, lot 228299.Controls performed as expected and all donor samples resulted negative as expected.Retention performed as expected.On (b)(6) 2016, pi performed cmv assay on customer's return samples, (b)(4), on the neo, using retention capture-cmv, lot c122 and retention capture cmv indicator cell, lot 228299.Controls performed as expected.Customer's samples reported as follows: (b)(4)--negative.(b)(4)--positive.(b)(4)--positive.(b)(4)--positive.(b)(4)--positive.(b)(4)--positive.(b)(4)--positive.Customer's issue was reproduced with 6 out of 7 samples.Customer issue was reproduced with returned samples.Returned samples were negative on previous donations, but current cmv status is unknown.
Event or Problem Description
On (b)(6) 2016, a customer reported unexpected positive results when testing a donor sample on the cmv assay on the galileo neo instrument using capture-cmv indicator red cells.

• Brand Name: CAPTURE-CMV INDICATOR RED CELLS
• Common Device Name: ANTI-IGG AND ANTI-IGM COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5823260
• Report Number: 1034569-2016-00178
• Device Sequence Number: 481948
• Product Code: KSF
• UDI-Device Identifier: 10888234001232
• UDI-Public: 10888234001232
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K910003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 07/26/2016

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: 08/05/2016
• Device Catalogue Number: 0066238
• Device Lot Number: 228299
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2016
• Initial Report FDA Received Date: 07/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1