MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-CMV; SOLID PHASE SYSTEM FOR DETECTION OF IGG AND IGM ANTIBODIES TO CYTOMEGALOVIRUS

Catalog Number	0066206
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No electronic connection method for manual capture workstation was available, for use by immucor technical support.The blood sample was from a donor, and further testing was not possible because there was not enough sample volume remaining.No extra sample vol to continue testing.
Event or Problem Description
On (b)(6) 2016, a customer site reported an unexpectedly positive cmv test when using capture-cmv on a manual capture workstation.

• Brand Name: CAPTURE-CMV
• Common Device Name: SOLID PHASE SYSTEM FOR DETECTION OF IGG AND IGM ANTIBODIES TO CYTOMEGALOVIRUS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 5643983
• Report Number: 1034569-2016-00105
• Device Sequence Number: 306789
• Product Code: LJO
• UDI-Device Identifier: 10888234001157
• UDI-Public: 10888234001157
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/10/2016

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: 05/18/2016
• Device Catalogue Number: 0066206
• Device Lot Number: C121
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1