MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-P; SOLID PHASE SYSTEM FOR THE DETECTION OF IGG ANTIBODIES TO PLATELETS

Catalog Number	0066251
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The immucor laboratory was unable to assess the patient sample because the blood sample was not submitted to immucor.No blood sample supplied.
Event or Problem Description
On (b)(6) 2017, it was determined that testing at a customer site on (b)(6) 2017 yielded an unexpectedly compatible pair of capture-p result outcomes.

• Brand Name: CAPTURE-P
• Common Device Name: SOLID PHASE SYSTEM FOR THE DETECTION OF IGG ANTIBODIES TO PLATELETS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6392875
• Report Number: 1034569-2017-00055
• Device Sequence Number: 13588601
• Product Code: KSZ
• UDI-Device Identifier: 10888234001300
• UDI-Public: 10888234001300
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK860017
• 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): 03/09/2017

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: 02/23/2017
• Device Catalogue Number: 0066251
• Device Lot Number: P172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR