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

Catalog Number	0006428
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product is expired.Performed a dhr review for capture p indicator red cells lot 226342 for performance in manual capture prior to release.Dhr quality review deemed all specifications as being met and released product to market on 24aug2016.
Event or Problem Description
On 04oct2016, a customer reported unexpected platelet crossmatch reactions with capture-p ready indicator cells lot 226342.On (b)(6) 2016, 8 donors samples were tested with one patient sample using capture-p lot p171 and capture p indicator cells lot 226342, and 4 of the 8 donors resulted compatible.On (b)(6) 2016, they tested the same patient sample with 8 different samples from (b)(6) 2016 with capture-p lot p171 and capture p indicator cells lot 226343 and all 8 donors were incompatible.

• Brand Name: CAPTURE-P INDICATOR RED CELLS
• Common Device Name: ANTI-IGG 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: 6069902
• Report Number: 1034569-2016-00278
• Device Sequence Number: 11179003
• Product Code: KSF
• UDI-Device Identifier: 10888234001256
• UDI-Public: 10888234001256
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK860017/1
• 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): 11/01/2016

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: 09/29/2016
• Device Catalogue Number: 0006428
• Device Lot Number: 226342
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1