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

Catalog Number 0066246

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

The capture-p process is a manual user process.Immucor technical support used phone support.No blood sample or customer site product was returned to immucor for investigation.The customer commented that the member of staff performing the original manual testing was a trainee and the customer determined that they had made a user sample addition error.Manual user process with phone support.

Event Description

On (b)(6) 2016, a customer site reported ten (10) unexpected negative platelet crossmatch tests when tested against one single blood sample, when using capture-p.

• Brand Name: CAPTURE-P
• Type of Device: SOLID PHASE SYSTEM FOR THE DETECTION OF IGG ANTIBODIES TO PLATELETS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 5966769
• MDR Text Key: 55670624
• Report Number: 1034569-2016-00244
• Device Sequence Number: 1
• Product Code: KSS
• UDI-Device Identifier: 10888234001270
• UDI-Public: 10888234001270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK860017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: 0066246
• Device Lot Number: P171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1